Chrysalis Intelligence · Sponsors · Physio-Control, Inc.

Physio-Control, Inc.

Redmond, WA, US · 2 510(k) clearances · 83 PMAs · 26 recalls

← Library Overview New Filings 510(k) Explorer Recalls Explorer All Sponsors All Product Codes Orphan Products Signals
Total clearances
2
2024-04-30 → 2025-10-14
Last 12 months
1
Product codes
2
Most recent
2025-10-14
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
MPD — — — 1 2025-10-14
DSA Cable, Transducer And Electrode, Patient, (Including Connector) Class II Cardiovascular 1 2024-04-30
Class III

PMA approvals (83)

Total PMA records
83
Originals + supplements
Distinct product codes
1
First decision
2020-01-17
Most recent
2026-08-06
DatePMA #Trade nameTypeCodeDevice nameSpecialty
2026-08-06 P160026-S071 LIFEPAK® 35 monitor/defibrillator Real-Time Process MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2026-07-30 P170018-S025 LIFEPAK® CR2 Defibrillator 30-Day Notice MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2026-07-30 P160026-S070 LIFEPAK 1000 DEFIBRILLATOR, LIFEPAK 20 DEFIBRILLATOR/ MONITOR, LIFEPAK 20E DEFIBRILLATOR/ MONITOR, LIFEPAK 15 MONITOR/DE 30-Day Notice MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2026-06-25 P160026-S068 LIFEPAK® 15 monitor/defibrillator 30-Day Notice MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2026-05-06 P160026-S067 LIFEPAK® 15 monitor/defibrillator Real-Time Process MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2026-03-05 P160026-S066 LIFEPAK 35 monitor/defibrillator 30-Day Notice MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2026-02-23 P160026-S065 LIFEPAK® 35 monitor/defibrillator Real-Time Process MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2025-12-04 P160026-S063 LIFEPAK® 35 Defibrillator/monitor 30-Day Notice MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2025-11-21 P160026-S064 LIFEPAK® 35 monitor/defibrillator 30-Day Notice MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2025-11-06 P170018-S023 LIFEPAK® CR2 Automated External Defibrillator Real-Time Process MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2025-10-14 P160026-S062 LIFEPAK 1000 defibrillator 30-Day Notice MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2025-09-29 P170018-S024 LIFEPACK® CR2 Automated External Defibrillator (AED) 30-Day Notice MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2025-06-30 P160026-S061 LIFEPAK FLEX™ Lithium-ion Battery 30-Day Notice MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2025-06-20 P170018-S022 LIFEPAK® CR2 Defibrillator 30-Day Notice MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2025-06-20 P160026-S060 LIFEPAK 15 monitor/defibrillator; LIFEPAK 35 monitor/defibrillator; LIFEPAK 20e defibrillator/monitor; LIFEPAK 1000 defi 30-Day Notice MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2025-06-20 P160026-S059 LIFEPAK 35 monitor/defibrillator 30-Day Notice MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2025-04-03 P160026-S057 LIFEPAK 1000 DEFIBRILLATOR, LIFEPAK 20 DEFIBRILLATOR/ MONITOR, LIFEPAK 20E DEFIBRILLATOR/ MONITOR, LIFEPAK 15 MONITOR/DE 30-Day Notice MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2025-03-17 P160026-S053 LIFEPAK® 35 monitor/defibrillator Real-Time Process MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2025-02-03 P160026-S056 LIFEPAK® 1000 Defibrillator 30-Day Notice MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2025-01-31 P160026-S055 LIFEPAK 1000 DEFIBRILLATOR, LIFEPAK 20 DEFIBRILLATOR/ MONITOR, LIFEPAK 20E DEFIBRILLATOR/ MONITOR, LIFEPAK 15 MONITOR/DE 30-Day Notice MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2025-01-27 P160026-S054 LIFEPAK® 15 monitor 30-Day Notice MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2024-10-17 P170018-S021 LIFEPAK CR2 Defibrillator 30-Day Notice MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2024-10-01 P170018-S020 LIFEPAK® CR2 Defibrillator 30-Day Notice MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2024-09-25 P160026-S051 LIFEPAK® 1000 Defibrillator 30-Day Notice MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2024-09-13 P160026-S052 LIFEPAK 35 monitor/defibrillator 30-Day Notice MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2024-06-26 P160026-S050 LIFEPAK 35 Monitor/Defibrillator, LIFEPAK FLEX Battery 30-Day Notice MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2024-05-24 P160026-S049 LIFEPAK 35 Monitor/Defibrillator 30-Day Notice MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2024-04-29 P160026-S048 LIFEPAK® 35 Monitor/Defibrillator 30-Day Notice MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2024-04-29 P160026-S047 LIFEPAK® 35 Monitor/Defibrillator 30-Day Notice MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2024-04-23 P170018-S019 LIFEPAK® CR2 defibrillator 30-Day Notice MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2024-04-12 P160026-S040 LIFEPAK® 35 Monitor/Defibrillator Normal 180 Day Track MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2024-02-27 P160026-S046 LIFEPAK® 1000 Defibrillator, LIFEPAK® 15 Monitor/Defibrillator 30-Day Notice MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2023-12-22 P160026-S042 LIFEPAK® 15 monitor/defibrillator Real-Time Process MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2023-12-15 P160026-S044 LIFEPAK® 15 monitor/defibrillator Real-Time Process MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2023-11-02 P160026-S045 LIFEPAK® 15 Defibrillator Lithium- ion Rechargeable Battery Accessory 30-Day Notice MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2023-10-25 P170018-S017 LIFEPAK® CR2 defibrillator Real-Time Process MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2023-10-18 P160026-S043 LIFEPAK® 15 monitor/defibrillator Special (Immediate Track) MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2023-10-11 P170018-S018 LIFEPAK® CR2 Defibrillator 30-Day Notice MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2023-08-31 P170018-S016 LIFEPAK® CR2 Defibrillator 30-Day Notice MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2023-08-16 P160026-S041 LIFEPAK® 15 Defibrillator 30-Day Notice MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2023-07-03 P160026-S039 LIFEPAK® 1000 Defibrillator Real-Time Process MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2023-04-18 P160026-S038 LIFEPAK CR® Plus defibrillator; LIFEPAK EXPRESS® defibrillator; LIFEPAK 1000® defibrillator 30-Day Notice MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2023-04-18 P160012-S007 LIFEPAK CR® Plus Defibrillator, LIFEPAK EXPRESS® Defibrillator, and LIFEPAK 1000® defibrillator 30-Day Notice MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2023-02-15 P160012-S005 QUIK-PAK™ Electrodes Real-Time Process MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2023-01-10 P170018-S015 LIFEPAK® CR2 Defibrillator Real-Time Process MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2023-01-04 P160026-S037 LIFEPAK Automated External Defibrillators (AEDs) 30-Day Notice MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2022-12-12 P160026-S036 LIFEPAK® 15 Monitor/Defibrillator 30-Day Notice MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2022-11-10 P160026-S035 LIFEPAK Automated External Defibrillators (AEDs) 30-Day Notice MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2022-10-27 P160026-S034 LIFEPAK Automated External Defibrillators (AEDs) 30-Day Notice MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2022-09-27 P170018-S014 LIFEPAK® CR2 Defibrillator Real-Time Process MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2022-08-16 P160026-S033 QUIK-COMBO® Therapy Cable 30-Day Notice MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2022-08-05 P160026-S030 LIFEPAK 15 Monitor/Defibrillator Real-Time Process MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2022-07-28 P160026-S032 LIFEPAK® 15 Monitor/Defibrillator, LIFEPAK® 20e Defibrillator/Monitor 30-Day Notice MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2022-07-28 P160026-S031 LIFEPAK Automated External Defibrillator (AED) Real-Time Process MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2022-07-20 P160012-S006 QUIK-PAK Electrodes Real-Time Process MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2021-11-29 P160012-S002 QUIK-PAK Electrodes Normal 180 Day Track MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2021-11-02 P160026-S028 Physio-Control LIFEPAK® 20e defibrillator/monitor Real-Time Process MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2021-09-15 P160026-S029 QUIK-COMBO® Therapy Cable (a necessary AED accessory of the LIFEPAK® 15 Monitor/Defibrillator) 30-Day Notice MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2021-07-08 P160026-S015 LIFEPAK Automated External Defibrillators (AEDs) Normal 180 Day Track MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2021-07-08 P160012-S003 Infant/Child Reduced Energy Defibrillation Electrodes Normal 180 Day Track MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2021-06-23 P160026-S027 LIFEPAK 15 Monitor/Defibrillator 30-Day Notice MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2021-06-22 P160026-S026 LIFEPAK 15 Monitor/Defibrillator 30-Day Notice MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2021-06-08 P170018-S013 LIFEPAK® CR2 Defibrillator 30-Day Notice MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2021-04-27 P160026-S025 LIFEPAK® 1000 Defibrillator 30-Day Notice MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2021-04-22 P160026-S023 LIFEPAK Automated External Defibrillator (AED) Real-Time Process MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2021-03-19 P160026-S024 LIFEPAK 15 Monitor/Defibrillator and LIFEPAK 20e Defibrillator/Monitor 30-Day Notice MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2021-02-16 P170018-S012 LIFEPAK CR2 Automated External Defibrillator Special (Immediate Track) MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2020-10-22 P170018-S011 LIFEPAK CR2 Defibrillator 30-Day Notice MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2020-10-07 P170018-S009 LIFEPAK CR2 Defibrillator 30-Day Notice MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2020-10-04 P170018-S010 LIFEPAK CR2 Automated External Defibrillator 30-Day Notice MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2020-09-17 P170018-S008 LIFEPAK CR2 Automated External Defibrillator 30-Day Notice MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2020-09-16 P160026-S020 LIFEPAK Automated External Defibrillators Real-Time Process MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2020-08-27 P170018-S007 LIFEPAK CR2 Defibrillator Real-Time Process MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2020-07-29 P160026-S017 LIFEPAK Automated External Defibrillators (AEDs) Real-Time Process MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2020-07-28 P160026-S016 LIFEPAKAutomated External Defibrillators (AEDs) Real-Time Process MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2020-07-13 P170018-S005 LIFEPAK CR2 Defibrillator Real-Time Process MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2020-07-09 P160026-S018 LIFEPAK Automated External Defibrillators (AEDs) Real-Time Process MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2020-06-18 P160026-S019 LIFEPAK Automated External Defibrillators (AEDs) 30-Day Notice MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2020-05-20 P170018-S006 LIFEPAK CR2 Automated External Defibrillator (AED) 30-Day Notice MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2020-05-13 P160012-S004 LIFEPAK CR Plus defibrillator and LIFEPAK EXPRESS defibrillator 30-Day Notice MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2020-02-21 P160026-S012 LIFEPAK 15 monitor/defibrillator Real-Time Process MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2020-02-13 P160026-S014 LIFEPAK Automated External Defibrillators (AEDs) Real-Time Process MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2020-01-17 P160026-S013 LIFEPAK Automated External Defibrillators (AEDs) Real-Time Process MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
Safety

Recalls (26)

Class I (serious)
0
Risk of injury / death
Total recalls
26
Currently ongoing
22
Most recent
2026-04-13
DateSeverityStatusRecall # ProductCodeReason
2026-04-13 Class II Ongoing Z-2065-2026 LIFEPAK 15, REF: 99577-000025, 99577-000047, 99577-001256, 99577-001217, 99577-001241, 99577-001255, 99577-001219, 99577… — Some defibrillators serviced between July 2023 through November 2025 were serviced without objective evidence that a Performance Inspection Procedure (PIP) was …
2026-01-21 Class II Ongoing Z-1544-2026 PHYSIO CONTROL INFANT/CHILD Reduced Energy Defibrillator Electrodes Catalog Numbers: 11101-000016 UDI-DI code: 0072190… — Due to pediatric defibrillator electrode delamination
2025-07-22 Class II Ongoing Z-2499-2025 LIFEPAK CR2 Part / Catalog Numbers / UDI-DI code: CR2-2-001451 99512-001434 883873785911 LIFEPAK CR2: The LIFEPAK C… — Due to required inspections not being performed on products/units that have gone through servicing.
2025-07-22 Class II Ongoing Z-2498-2025 LIFEPAK 1000 Part / Catalog Numbers / UDI-DI code: 320371500023 / 99425-000025 / 885074698953 320371500229 / 99425-000… — Due to required inspections not being performed on products/units that have gone through servicing.
2025-07-22 Class II Ongoing Z-2497-2025 LIFEPAK 15 Part / Catalog Numbers / UDI-DI code: V15-7-000022 / 99577-001957 / 883873871690 V15-2-000051 / 99577-0000… — Due to required inspections not being performed on products/units that have gone through servicing.
2025-02-03 Class II Ongoing Z-1232-2025 LIFEPAK 20e REF 99507-000001 The AED mode is to be used only on patients in cardiopulmonary arrest. — Incorrect keypad was incorrectly installed onto a defibrillator/monitor.
2025-01-21 Class II Ongoing Z-1184-2025 LIFEPAK 15 V4/Masimo Rainbow Sensors: Masimo¿ RD rainbow Adt 8¿ SpCO, SpO2, and SpMet, Adult Adhesive Sensors REF 119… — Due to an error message that prevents users from utilizing carboxyhemoglobin saturation and methemoglobin saturation sensors on their monitor/defibrillator syst…
2025-01-21 Class II Ongoing Z-1102-2025 LIFEPAK 35 ECG cable REF 11111-000041 — Product shipped with incorrect IFU. IFU does not include proper cleaning/disinfection instructions
2024-08-30 Class II Ongoing Z-0230-2025 LIFEPAK 15 (LP15) Model/Catalog Numbers: o 97577-000101 o 99577-000046 o 99577-000055 o 99577-000061 o 99577-000076… — Due to an out of tolerance tool being used on monitor/defibrillator systems.
2024-08-09 Class II Ongoing Z-0142-2025 STERILIZABLE INTERNAL DEFIBRILLATION PADDLES REF LP20 STERILIZABLE INTERNAL DEFIBRILLATION PADDLES REF LP15 Defibril… — Due to customer complaints and out of box failures, the firm is conducting a voluntary recall as a result of product failures (cracks and over-molding separatio…
2023-11-06 Class II Ongoing Z-0567-2024 AC Power Adapter for use with the LIFEPAK 15 Monitor/Defibrillator, REF: 11140-000098 — AC Power Adapter (ACPA) may not charge the monitor/defibrillator batteries and may not allow the monitor/defibrillator to power on while plugged into the ACPA.
2023-09-29 Class II Ongoing Z-0305-2024 LIFEPAK 15, REF: 99577-001960, Part Number: V15-7-000026 — Their is a potential for battery pins to become loose within the defibrillator resulting in power issues.
2023-09-29 Class II Ongoing Z-0304-2024 LIFEPAK 15, REF: 99577-001958, Part Number: V15-7-000023 — Their is a potential for battery pins to become loose within the defibrillator resulting in power issues.
2023-09-29 Class II Ongoing Z-0303-2024 LIFEPAK 15, REF: 99577-001957, Part Number V15-5-000586 and V15-7-000022 — Their is a potential for battery pins to become loose within the defibrillator resulting in power issues.
2023-09-29 Class II Ongoing Z-0302-2024 LIFEPAK 15, REF: 99577-001956, Part Number V15-7-000021 — Their is a potential for battery pins to become loose within the defibrillator resulting in power issues.
2023-09-29 Class II Ongoing Z-0301-2024 LIFEPAK 15, REF: 99577-001955, Part Number V15-5-000584 and V15-7-000020 — Their is a potential for battery pins to become loose within the defibrillator resulting in power issues.
2023-09-29 Class II Ongoing Z-0300-2024 LIFEPAK 15, REF: 99577-001373, Part Number V15-7-000002 — Their is a potential for battery pins to become loose within the defibrillator resulting in power issues.
2023-09-29 Class II Ongoing Z-0299-2024 LIFEPAK 15, REF: 99577-001255, Part Number V15-2-001602 — Their is a potential for battery pins to become loose within the defibrillator resulting in power issues.
2023-09-29 Class II Ongoing Z-0298-2024 LIFEPAK 15, REF: 99577-000061, Part Number V15-2-000067 — Their is a potential for battery pins to become loose within the defibrillator resulting in power issues.
2023-09-29 Class II Ongoing Z-0297-2024 LIFEPAK 15, REF: 99577-000055, Part Number V15-2-000061 — Their is a potential for battery pins to become loose within the defibrillator resulting in power issues.
2023-09-29 Class II Ongoing Z-0296-2024 LIFEPAK 15, REF: 99577-000046, Part Number V15-2-000051 — Their is a potential for battery pins to become loose within the defibrillator resulting in power issues.
2022-01-13 Class III Terminated Z-0745-2022 HeartSine Samaritan PAD, SAM 350P Semi-Automatic Defibrillator, used with Pad-Pak — Semi-automatic defibrillators shipped out by Stryker without battery and electrode packs.
2021-01-14 Class II Ongoing Z-1189-2021 PHYSIO CONTROL LIFEPAK CR2 Defibrillator 3321605-xxx The LIFEPAK CR2 defibrillator is designed for indoor and outdo… — Due to complaints received regarding missing lid magnets which may result in premature battery depletion.
2020-04-24 Class II Terminated Z-2360-2020 Infant Child Starter Kits, Part Number: 3202784-009, containing Infant/Child Reduced Energy Defibrillation Electrodes, … — Packaging of infant child reduced energy electrodes was not properly sealed.
2020-04-24 Class II Terminated Z-2359-2020 Infant/Child Reduced Energy Defibrillation Electrodes, Part Number: 3202380-006, for use with LIFEPAK 1000 defibrillator… — Packaging of infant child reduced energy electrodes was not properly sealed.
2020-03-20 Class II Terminated Z-1633-2020 LifePAK 500 Automated External Defibrillator, model numbers: 3005400-XXX, U3005400-XXX, 3011790-XXX/, U3011790-XXX - Pro… — Automated External Defibrillators may not detect a patient connection due to mechanical wear-through of the contact plating on the therapy connector. The wear-…
Filings

All 510(k) clearances (2)

Date K-number Device Code Class Specialty
2025-10-14 K253099 LIFEPAK 15 AC Power Adapter (41577-000333) MPD — —
2024-04-30 K240156 LIFEPAK® Invasive Pressure Adapter Cable (Interfaces with ICU Medical Transpack IV Invasive Pressure Transducers (or equivalent)) (11230-000021); LIFEPAK® Invasive Pressure Adapter Cable (interfaces with Edwards Lifesciences TruWave Invasive Pressure Transducers (or equivalent)) (11230-000024) DSA Class II Cardiovascular
Data source: openFDA · Generated 2026-08-26 09:36 · Last ingest 2026-08-26T13:35:45.365163 · Pipeline: Chrysalis Intelligence