Chrysalis Intelligence · Sponsors · Fisher & Paykel Healthcare, Ltd.

Fisher & Paykel Healthcare, Ltd.

Auckland, NZ · 27 510(k) clearances · 3 recalls

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Total clearances
27
2020-03-09 → 2025-12-19
Last 12 months
3
Product codes
9
Most recent
2025-12-19
Name variants in FDA filings: Fisher & Paykel Healthcare, Ltd. / Fisher & Paykel Healthcare Limited / Fisher & Paykel Healthcare
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
BTT Humidifier, Respiratory Gas, (Direct Patient Interface) Class II Anesthesiology 13 2025-12-19
BZD Ventilator, Non-Continuous (Respirator) Class II Anesthesiology 5 2025-06-18
CBK — — — 2 2025-09-10
MNT Sv70 Ventilator Class II Anesthesiology 2 2024-08-09
SGR — — — 1 2025-11-19
BZR — — — 1 2025-07-14
CBP Valve, Non-Rebreathing Class II Anesthesiology 1 2024-08-09
QAV High Flow/High Velocity Humidified Oxygen Delivery Device Class II Anesthesiology 1 2023-01-27
CAF — — — 1 2021-12-10
Safety

Recalls (3)

Class I (serious)
0
Risk of injury / death
Total recalls
3
Currently ongoing
3
Most recent
2025-09-18
DateSeverityStatusRecall # ProductCodeReason
2025-09-18 Class II Ongoing Z-0158-2026 Airvo 2, REF: PT101US, and myAirvo 2, REF: PT100US, used with Disinfection Kit User Manual, REF: UI-185043723 — When unintentionally disconnected from power source, humidifier device (used to deliver high flow warmed and humidified respiratory gases) may sound audible ale…
2024-08-07 Class II Ongoing Z-3262-2024 PT301US Airvo 3 Respiratory Support Device with software version 1.2.0 and/or 1.5.1 The Airvo 3 is intended to provi… — Due to a software issue, affected devices that are set up with High Pressure Oxygen (HPO), if the flow alignment alarm occurs, the device will deliver room air …
2024-04-02 Class II Ongoing Z-1823-2024 Airvo 2 Humidifier, REF: PT101US, and myAirvo 2 Humidifier, REF: PT100US — Humidifier devices, used to deliver high flow respiratory therapy to patients, manufactured before 14 August 2017, have a speaker configuration that may result …
Filings

All 510(k) clearances (27)

Date K-number Device Code Class Specialty
2025-12-19 K253479 Optiflow Switch+ Filtered Nasal Interface with CO2 Sampling (AA042J) BTT Class II Anesthesiology
2025-11-19 K250651 OptiPAP Junior Flexi Tube US (OPTIPAPFUS); OptiPAP Junior Nasal Prongs XXS (OPTIPAPPXXS); OptiPAP Junior Nasal Prongs XS (OPTIPAPPXS); OptiPAP Junior Nasal Prongs S (OPTIPAPPS); OptiPAP Junior Nasal Prongs M (OPTIPAPPM); OptiPAP Junior Nasal Prongs L (OPTIPAPPL); OptiPAP Junior Nasal Prongs XL (OPTIPAPPXL); OptiPAP Junior Nasal Mask XXS (OPTIPAPMXXS); OptiPAP Junior Nasal Mask XS (OPTIPAPMXS); OptiPAP Junior Nasal Mask S (OPTIPAPMS); OptiPAP Junior Nasal Mask M (OPTIPAPMM); OptiPAP Jun SGR — —
2025-09-10 K252173 F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits – Size A (ONIV117A); F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits – Size B (ONIV117B); F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits – Size C (ONIV117C); F&P OptiNIV ONIV117-F Hospital Vented Full Face Mask with optional Expiratory Filter Compatible with Single-limb Circuits - Size A (ONIV117A-F); F&P OptiNIV ONIV117-F Hospital Vented Full CBK — —
2025-07-14 K243917 F&P Optiflow Air/Oxygen Flow Source BZR — —
2025-06-25 K251611 Optiflow+ Nasal Cannula - Small (OPT942); Optiflow+ Nasal Cannula - Medium (OPT944); Optiflow+ Nasal Cannula - Large (OPT946); Optiflow+ Nasal Cannula Small (MYOPT9SMALL); Optiflow+ Nasal Cannula Medium (MYOPT9MEDIUM); Optiflow+ Nasal Cannula Large (MYOPT9LARGE) BTT Class II Anesthesiology
2025-06-18 K243583 F&P Nova Nasal Mask BZD Class II Anesthesiology
2024-08-09 K234053 F&P Optiflow Flow Diverter CBP Class II Anesthesiology
2024-08-09 K233643 F&P Airvo 3 NIV (PT311US) MNT Class II Anesthesiology
2024-08-08 K234058 F&P Optiflow Filtered Nasal Interface with Anesthesia Mask Compatibility (AA041J) BTT Class II Anesthesiology
2024-06-13 K233821 F&P Optiflow Oxygen Kit (AA451J) BTT Class II Anesthesiology
2024-05-08 K222292 F&P myAirvo 3 BTT Class II Anesthesiology
2024-02-07 K231956 F&P Optiflow+ Duet Nasal Cannula BTT Class II Anesthesiology
2023-09-05 K223684 F&P 820 Humidification System BTT Class II Anesthesiology
2023-06-29 K221436 F&P 950 Accessory Breathing Circuit Kits BZD Class II Anesthesiology
2023-06-16 K220703 F&P 950 Respiratory Humidifier BTT Class II Anesthesiology
2023-05-17 K223696 F&P Solo Mask Range BZD Class II Anesthesiology
2023-04-06 K222197 F&P Optiflow Junior 2/2+ Nasal Cannula Interface Range BTT Class II Anesthesiology
2023-01-27 K221338 F&P Airvo 3 QAV Class II Anesthesiology
2022-04-22 K212031 F&P 850 AirSpiral Adult NIV and NHF Circuit Kit BTT Class II Anesthesiology
2022-03-18 K212371 F&P Evora Full Face Mask BZD Class II Anesthesiology
2022-01-28 K211096 Optiflow Oxygen Kit BTT Class II Anesthesiology
2021-12-10 K211560 Airvo Nebulizer Adapter CAF — —
2021-04-14 K203449 F&P Visairo NIV Mask Range CBK — —
2021-03-16 K201723 F&P Optiflow Nasal Oxygen Cannula with CO2 Sampling BTT Class II Anesthesiology
2020-06-02 K200089 F&P Evora Nasal Mask Nasal A Model (Small, Medium, Large, Wide), F&P Evora Nasal Mask Nasal Fit Pack/ SML (Small/Medium/Large) A Model, F&P Evora Nasal Mask Nasal Sleep Lab (Small, Medium, Large, Wide), F&P Evora Nasal Mask Nasal Fit Pack / SML (Small/Medium/Large) Sleep Lab Model BZD Class II Anesthesiology
2020-03-19 K191818 F&P Optiflow 3S Nasal Cannula (Small, Medium, Large) BTT Class II Anesthesiology
2020-03-09 K191624 F&P Nivairo RT047 Vented Hospital Full Face Mask, Anti-Asphyxiation Valve Version MNT Class II Anesthesiology
Data source: openFDA · Generated 2026-08-26 09:36 · Last ingest 2026-08-26T13:35:45.365163 · Pipeline: Chrysalis Intelligence