# Fisher & Paykel Healthcare, Ltd.

- Location (FDA's records): Auckland, NZ
- FDA decisions: 83 (1988–2025): 83 510(k) clearances
- Names in FDA's records: Fisher & Paykel Healthcare, Ltd. (70); Fisher & Paykel Healthcare Limited (8); Fisher & Paykel Healthcare (5)
- Product codes: BZD (30), BTT (28), MNT (3), CBK (3), CAH (3), CBP (3), BZE (3), ILY (2), CAF (1), SGR (1), BZR (1), HIF (1)
- 510(k) review time since 2016: median 230 days, against 221 for FDA's reviews in the same codes and years (9 of 25 faster)
- Predicates its devices cite: 113 (83 its own); citations of its devices by later devices: 142 (83 its own)
- Recalls linked to its devices: 16 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Fisher & Paykel Electronics, Ltd.: 8 (https://510kreport.com/company/fisher-paykel-electronics)
- Respironics, Inc.: 3 (https://510kreport.com/company/respironics)
- Fisher and Paykel Healthcare Limited: 2 (https://510kreport.com/company/fisher-and-paykel-healthcare)
- Resmed, Ltd.: 2 (https://510kreport.com/company/resmed)
- Aerogen, Ltd.: 1 (https://510kreport.com/company/aerogen)
- Allegiance Healthcare Corp.: 1 (https://510kreport.com/company/allegiance-healthcare)
- Drager, Inc.: 1 (https://510kreport.com/company/drager)
- Aragona AB Co.: 1 (https://510kreport.com/company/aragona)

## Firms that cite its devices most
- Fisher and Paykel Healthcare Limited: 4 (https://510kreport.com/company/fisher-and-paykel-healthcare)
- Draeger Medical, Inc.: 4 (https://510kreport.com/company/draeger-medical)
- Medline Industries, Inc.: 3 (https://510kreport.com/company/medline-industries)
- Hamilton Medical AG: 3 (https://510kreport.com/company/hamilton-medical)
- Vincent Healthcare Products Limited: 3 (https://510kreport.com/company/vincent-healthcare-products)
- Flexicare Medical Limited.: 3 (https://510kreport.com/company/flexicare-medical)
- Vyaire Medical, Inc.: 2 (https://510kreport.com/company/vyaire-medical)
- Teleflex Medical: 2 (https://510kreport.com/company/teleflex-medical)

## Its most-cited devices
- K073706: Respiratory Humidifier, Model MR850 (2008), cited by 11
- K983112: Respiratory Humidifier, Model # MR850 (1998), cited by 9
- K162553: AirSpiral Heated Breathing Tube (2018), cited by 8
- K131895: Airvo 2 Humidifier, Myairvo 2 Humidifier (2013), cited by 7
- K033710: MR850 Respiratory Humidifier, Model MR850JHU (2004), cited by 6
- K103767: Dual Heated Infant Vreathing Cirouits (2012), cited by 6

## Recent decisions
- K253479: Optiflow Switch+ Filtered Nasal Interface with CO2 Sampling (AA042J) (Dec 19, 2025)
- 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 (Nov 19, 2025)
- 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 (Sep 10, 2025)
- K243917: F&P Optiflow Air/Oxygen Flow Source (Jul 14, 2025)
- 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) (Jun 25, 2025)
- K243583: F&P Nova Nasal Mask (Jun 18, 2025)
- K234053: F&P Optiflow Flow Diverter (Aug 9, 2024)
- K233643: F&P Airvo 3 NIV (PT311US) (Aug 9, 2024)

Source page: https://510kreport.com/company/fisher-paykel-healthcare