Chrysalis Intelligence · Sponsors · ZOLL Medical Corporation

ZOLL Medical Corporation

Chelsmford, MA, US · 2 510(k) clearances · 77 PMAs · 10 recalls (1 Class I)

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Total clearances
2
2021-03-09 → 2024-12-13
Last 12 months
0
Product codes
2
Most recent
2024-12-13
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
CBK — — — 1 2024-12-13
MWI — — — 1 2021-03-09
Class III

PMA approvals (77)

Total PMA records
77
Originals + supplements
Distinct product codes
3
First decision
2020-01-24
Most recent
2026-07-16
DatePMA #Trade nameTypeCodeDevice nameSpecialty
2026-07-16 P160015-S028 AED 3; CPR Uni-Padz Normal 180 Day Track No User Fee MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2026-07-14 P160022-S053 OneStep CPR Complete Electrodes, OneStep CPR Complete Adult/Child Electrodes, OneStep CPR AA Electrodes, OneStep CPR Ele 30-Day Notice MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2026-06-05 P160022-S051 CPR Uni-padz Electrode Real-Time Process MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2026-05-20 P160022-S052 SurePower I; SurePower II 30-Day Notice MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2026-04-28 P160033-S011 Powerheart® G5 Real-Time Process MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2026-04-28 P160022-S050 CPR Uni-padz, CPR-D-padz, OneStep Basic, OneStep CPR, OneStep CPR A/A, OneStep Pediatric, OneStep Pediatric CPR, OneStep Real-Time Process MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2025-12-30 P160022-S049 OneStep CPR Complete Electrode 30-Day Notice MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2025-12-18 P160022-S046 X Series®; Propaq MD®; AED 3™ BLS; Zenix Professional Defibrillators Normal 180 Day Track No User Fee MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2025-12-18 P160015-S025 AED 3™ Normal 180 Day Track No User Fee MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2025-12-09 P160022-S048 ZOLL Zenix Monitor/Defibrillator; ZOLL Zenix Multi-function Cable; ZOLL Zenix CPR Complete Electrodes; ZOLL OneStep Paci Real-Time Process MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2025-09-29 P160022-S036 ZOLL Zenix® Monitor/Defibrillator Normal 180 Day Track MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2025-09-22 P160022-S047 CPR Uni-padz Electrode Normal 180 Day Track No User Fee MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2025-09-22 P160015-S026 CPR-D-padz Electrode Normal 180 Day Track No User Fee MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2025-08-28 P160022-S042 AED Plus, AED 3, X Series, R Series, Propaq MD, AED Pro, AED 3 BLS Normal 180 Day Track No User Fee MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2025-08-28 P160015-S020 AED Plus, AED 3, X Series, R Series, Propaq MD, AED Pro, AED 3 BLS Normal 180 Day Track No User Fee MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2025-07-24 P160015-S024 AED Plus and Fully Automatic AED Plus 30-Day Notice MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2025-07-23 P890057-S029 MODEL 3100 FREQUENCY OSCILLATORY VENTILATOR Real-Time Process LSZ Ventilator, High Frequency Unknown
2025-07-11 P160022-S043 X Series®, R Series®, AED Pro®, AED 3™ BLS Professional Defibrillators, Pro-Padz Radiotransparent Electrode, SurePower™ Real-Time Process MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2025-07-11 P160015-S021 AED Plus and Fully Automatic AED Plus Real-Time Process MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2025-06-20 P160022-S040 X Series®, R Series®, AED Pro®, AED 3™ BLS Professional Defibrillators, Pro-Padz Radiotransparent Electrode, SurePower™ Real-Time Process MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2025-06-20 P160015-S018 AED Plus and Fully Automatic AED Plus Real-Time Process MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2025-05-30 P160022-S044 AED 3 BLS 30-Day Notice MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2025-05-30 P160015-S022 AED 3 Semi-Automatic, AED 3 Fully Automatic 30-Day Notice MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2025-05-07 P160022-S041 X Series®, R Series®, AED Pro®, AED 3™ BLS Professional Defibrillators, Pro-Padz Radiotransparent Electrode, SurePower™ 30-Day Notice MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2025-04-17 P160015-S019 AED Plus 30-Day Notice MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2025-03-05 P160022-S035 ZOLL OneStep Pediatric CPR Electrode Normal 180 Day Track MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2024-11-15 P890057-S027 3100 High Frequency Oscillating Ventilator (HFOV), Vyaire Model 31008 Oscillatory Ventilator 135 Review Track For 30-Day Notice LSZ Ventilator, High Frequency Unknown
2024-11-15 P160022-S039 R Series 30-Day Notice MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2024-11-12 P160022-S038 CPR-D-padz One-Piece Electrode Pad with Real CPR Help, OneStep CPR Complete Electrode, Pro-padz Biphasic Electrode, Pro- Real-Time Process MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2024-11-12 P160015-S016 CPR Uni-padz III Real-Time Process MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2024-10-16 P160015-S017 AED Plus and Fully Automatic AED Plus Special (Immediate Track) MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2024-08-22 P110024-S006 ResQCPR System Real-Time Process PIZ Combination Compression/Decompression Manual Chest Pump With Impedance Respiratory Valve Unknown
2024-05-30 P160022-S037 X Series, Propaq MD 30-Day Notice MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2024-02-20 P890057-S028 3100 High Frequency Oscillating Ventilator (HFOV), Vyaire Model 31008 Oscillatory Ventilator 135 Review Track For 30-Day Notice LSZ Ventilator, High Frequency Unknown
2023-12-21 P160033-S010 Powerheart® G5 AED Real-Time Process MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2023-08-23 P110024-S004 ResQCPR™ System 30-Day Notice PIZ Combination Compression/Decompression Manual Chest Pump With Impedance Respiratory Valve Unknown
2023-06-21 P160022-S015 Zoll OneStep CPR Cable, R Series OneStep Pacing Cable, X Series OneStep Cable, X Series/Propaq MD Multifunction Therapy Normal 180 Day Track MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2023-05-23 P160022-S034 CPR-D-padz electrode 30-Day Notice MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2023-05-23 P160015-S015 CPR-D-padz electrode 30-Day Notice MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2023-03-24 P160022-S033 Pedi-padz Multifunction Electrodes, Pro-padz Cardiology W/LVP Gel Electrodes, Pro-padz Radiolucent Liquid Gel Electrodes 30-Day Notice MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2023-03-23 P160033-S009 Powerheart G5 AED 30-Day Notice MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2023-02-17 P160022-S032 R Series MCU 20.01 software release Real-Time Process MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2022-12-20 P160022-S014 Zoll OneStep Cable, X Series Multifunction Therapy Cable, Propaq MD Multifunction Cable, X Series OneStep Cable, Multifu Normal 180 Day Track MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2022-12-19 P160022-S016 Zoll R series OneStep CPR Cable, R Series Onestep Pacing Cable, R Series MFC (Multi-Function Cable), Multifunction Thera Normal 180 Day Track MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2022-07-22 P890057-S025 Model 3100A/B High Frequency Oscillatory Ventilator Real-Time Process LSZ Ventilator, High Frequency Unknown
2022-05-27 P160015-S014 AED Plus 30-Day Notice MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2022-03-01 P160015-S013 AED Plus 30-Day Notice MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2021-11-17 P110024-S003 ResQCPR System Real-Time Process PIZ Combination Compression/Decompression Manual Chest Pump With Impedance Respiratory Valve Unknown
2021-10-07 P160033-S006 Powerheart G5 Pediatric Electrodes Real-Time Process MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2021-08-13 P160022-S030 X Series, AED Pro, Propaq MD 30-Day Notice MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2021-08-13 P160015-S012 AED 3, AED Plus 30-Day Notice MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2021-06-28 P160022-S019 ZOLL AED 3 BLS Device Normal 180 Day Track MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2021-06-28 P160015-S005 Zoll AED 3 and Zoll AED 3 Automatic Normal 180 Day Track MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2021-06-14 P160033-S008 Powerheart G5 AED 30-Day Notice MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2021-05-19 P160022-S028 X Series Advanced Devices Normal 180 Day Track No User Fee MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2021-03-26 P160022-S027 X Series, R Series, Propaq MD, and AED Pro 30-Day Notice MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2021-03-18 P160022-S026 ZOLL AED 3 BLS 30-Day Notice MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2021-03-18 P160015-S011 ZOLL AED 3 and ZOLL AED 3 Automatic 30-Day Notice MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2021-03-09 P160015-S010 AED Plus 30-Day Notice MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2021-02-02 P160033-S005 Powerheart® G5 AED 30-Day Notice MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2021-01-05 P160022-S025 X Series®, R Series®, AED Pro®, AED 3™ BLS Professional Defibrillators, Pro-Padz Radiotransparent Electrode, SurePower™ 30-Day Notice MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2021-01-05 P160022-S024 R Series Device 30-Day Notice MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2020-12-30 P160015-S009 ZOLL CPR Uni-padz 30-Day Notice MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2020-12-30 P160015-S008 ZOLL Stat-padz II Electrodes and ZOLL Pedi-padz II Electrodes 30-Day Notice MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2020-12-21 P160015-S007 Zoll AED 3 30-Day Notice MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2020-12-07 P160022-S023 X Series, R Series, and AED Pro 30-Day Notice MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2020-10-07 P160015-S006 ZOLL AED Plus and ZOLL Fully Automatic AED Plus 30-Day Notice MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2020-09-29 P160022-S022 X Series, Propaq MD, and R Series 30-Day Notice MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2020-09-29 P160022-S020 X Series and Propaq MD 30-Day Notice MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2020-09-17 P160022-S021 AED 3 BLS 30-Day Notice MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2020-08-25 P160022-S013 ZOLL X Series, Propaq MD, and X Series Advanced Normal 180 Day Track MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2020-07-07 P160022-S017 ZOLL R Series Real-Time Process MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2020-06-11 P160022-S018 X Series and Propaq MD 30-Day Notice MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2020-06-05 P160015-S004 AED 3 Defibrillator with Uni-Padz Normal 180 Day Track No User Fee MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2020-03-01 P160034-S002 Powerheart G3 Pro Automated External Defibrillator 30-Day Notice MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2020-02-28 P160015-S001 AED 3 defibrillator Normal 180 Day Track MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2020-01-24 P160015-S003 AED Plus 30-Day Notice MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
Safety

Recalls (10)

Class I (serious)
1
Risk of injury / death
Total recalls
10
Currently ongoing
10
Most recent
2025-02-13
DateSeverityStatusRecall # ProductCodeReason
2025-02-13 Class II Ongoing Z-1323-2025 Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: G5S-80A; Software Version: NA Product Descrip… — The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity).
2025-02-13 Class II Ongoing Z-1322-2025 Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5S-00A-TSO, (2) G5S-01A, (3) G5S-02A, (4) … — The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity).
2025-02-13 Class II Ongoing Z-1321-2025 Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: G5S-80C; Software Version: NA Product Descrip… — The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity).
2025-02-13 Class II Ongoing Z-1320-2025 Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5S-01C, (2) G5S-02C, (3) G5S-10C, (4) G5S-… — The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity).
2025-02-13 Class II Ongoing Z-1319-2025 Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5A-01C, (2) G5A-02C, (3) G5A-05C, (4) G5A-… — The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity).
2025-02-13 Class II Ongoing Z-1318-2025 Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5A-80C, (2) G5A-80C-TSO. Software Version… — The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity).
2025-02-13 Class II Ongoing Z-1317-2025 Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5A-80A, (2) G5A-80A-TSO. Software Version… — The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity).
2025-02-13 Class II Ongoing Z-1316-2025 Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5A-00A, (2) G5A-01A, (3) G5A-02A, (4) G5A-… — The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity).
2024-05-31 Class II Ongoing Z-2324-2024 ZOLL Powerheart G5 AED, Semi-Automatic, G5Sxxx Family -Automated external defibrillator (AED) is designed for treating l… — G5 Semi-Automatic AED is shipped, with a protective film over its front panel, to protect the screen and shock button from cosmetic damage during shipping. It …
2024-04-30 Class I Ongoing Z-2130-2024 ZOLL 731 Ventilator (EMV+, AEV, Eagle II) - for MRI Compatible Devices - Operator's Guide and Quick Reference Guide (QRG… — Operator's Guide & Quick Reference Guide (QRG) ZOLL 731 Ventilator for MRI Compatible Devices. Patient Safety Ventilator MRI information omitted from the manual…
Filings

All 510(k) clearances (2)

Date K-number Device Code Class Specialty
2024-12-13 K233486 731 Series Ventilator CBK — —
2021-03-09 K202375 ZOLL Propaq M MWI — —
Data source: openFDA · Generated 2026-08-26 09:36 · Last ingest 2026-08-26T13:35:45.365163 · Pipeline: Chrysalis Intelligence