Company · NZ
Fisher & Paykel Healthcare, Ltd.
FDA 510(k) clearances and medical device recalls filed under this name, 1988 to 2025. Name variants (Inc, Corp, punctuation) are merged.
83510(k) clearances (2 in 12 months)
21recalls (0 in 12 months)
18recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| BZD | Ventilator, Non-Continuous (Respirator) | 37 |
| BTT | Humidifier, Respiratory Gas, (Direct Patient Interface) | 36 |
| BZE | Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer | 3 |
| CAH | Filter, Bacterial, Breathing-Circuit | 3 |
| CBK | Ventilator, Continuous, Facility Use | 3 |
| CBP | Valve, Non-Rebreathing | 3 |
| MNT | Continuous, Minimal Ventilatory Support, Facility Use Ventilator | 3 |
| BZO | Set, Tubing And Support, Ventilator (W Harness) | 2 |
| FMT | Warmer, Infant Radiant | 2 |
| ILY | Lamp, Infrared, Therapeutic Heating | 2 |
| LBI | Unit, Neonatal Phototherapy | 2 |
| QAV | High Flow/High Velocity Humidified Oxygen Delivery Device | 2 |
| BXN | Stimulator, Nerve, Battery-Powered | 1 |
| BZR | Mixer, Breathing Gases, Anesthesia Inhalation | 1 |
| CAF | Nebulizer (Direct Patient Interface) | 1 |
| HIF | Insufflator, Laparoscopic | 1 |
| KOI | Stimulator, Nerve, Peripheral, Electric | 1 |
| SGR | Noninvasive Positive Airway Pressure System, Facility Use | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 19, 2025 | K253479 | Optiflow Switch+ Filtered Nasal Interface with CO2 Sampling (AA042J) Fisher & Paykel Healthcare, Ltd., NZ | BTT |
| Nov 19, 2025 | K250651 | OptiPAP Junior Flexi Tube US (OPTIPAPFUS); OptiPAP Junior Nasal Prongs XXS (OPTIPAPPXXS); OptiPAP Junior Nasal Prongs XS Fisher & Paykel Healthcare, Ltd., NZ | SGR |
| Sep 10, 2025 | K252173 | F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits Size A (ONIV117A); F&P OptiNIV Hospita Fisher & Paykel Healthcare, Ltd., NZ | CBK |
| Jul 14, 2025 | K243917 | F&P Optiflow Air/Oxygen Flow Source Fisher & Paykel Healthcare, Ltd., NZ | BZR |
| Jun 25, 2025 | K251611 | Optiflow+ Nasal Cannula - Small (OPT942); Optiflow+ Nasal Cannula - Medium (OPT944); Optiflow+ Nasal Cannula - Large (O Fisher & Paykel Healthcare, Ltd., NZ | BTT |
| Jun 18, 2025 | K243583 | F&P Nova Nasal Mask Fisher & Paykel Healthcare Limited, NZ | BZD |
| Aug 9, 2024 | K234053 | F&P Optiflow Flow Diverter Fisher & Paykel Healthcare, Ltd., NZ | CBP |
| Aug 9, 2024 | K233643 | F&P Airvo 3 NIV (PT311US) Fisher & Paykel Healthcare, Ltd., NZ | MNT |
| Aug 8, 2024 | K234058 | F&P Optiflow Filtered Nasal Interface with Anesthesia Mask Compatibility (AA041J) Fisher & Paykel Healthcare, Ltd., NZ | BTT |
| Jun 13, 2024 | K233821 | F&P Optiflow Oxygen Kit (AA451J) Fisher & Paykel Healthcare, Ltd., NZ | BTT |
| May 8, 2024 | K222292 | F&P myAirvo 3 Fisher & Paykel Healthcare, NZ | BTT |
| Feb 7, 2024 | K231956 | F&P Optiflow+ Duet Nasal Cannula Fisher & Paykel Healthcare, Ltd., NZ | BTT |
| Sep 5, 2023 | K223684 | F&P 820 Humidification System Fisher & Paykel Healthcare, Ltd., NZ | BTT |
| Jun 29, 2023 | K221436 | F&P 950 Accessory Breathing Circuit Kits Fisher & Paykel Healthcare, Ltd., NZ | BZD |
| Jun 16, 2023 | K220703 | F&P 950 Respiratory Humidifier Fisher & Paykel Healthcare, NZ | BTT |
| May 17, 2023 | K223696 | F&P Solo Mask Range Fisher & Paykel Healthcare, Ltd., NZ | BZD |
| Apr 6, 2023 | K222197 | F&P Optiflow Junior 2/2+ Nasal Cannula Interface Range Fisher & Paykel Healthcare, Ltd., NZ | BTT |
| Jan 27, 2023 | K221338 | F&P Airvo 3 Fisher & Paykel Healthcare, NZ | QAV |
| Apr 22, 2022 | K212031 | F&P 850 AirSpiral Adult NIV and NHF Circuit Kit Fisher & Paykel Healthcare, Ltd., NZ | BTT |
| Mar 18, 2022 | K212371 | F&P Evora Full Face Mask Fisher & Paykel Healthcare, Ltd., NZ | BZD |
| Jan 28, 2022 | K211096 | Optiflow Oxygen Kit Fisher & Paykel Healthcare, Ltd., NZ | BTT |
| Dec 10, 2021 | K211560 | Airvo Nebulizer Adapter Fisher & Paykel Healthcare Limited, NZ | CAF |
| Apr 14, 2021 | K203449 | F&P Visairo NIV Mask Range Fisher & Paykel Healthcare, Ltd., NZ | CBK |
| Mar 16, 2021 | K201723 | F&P Optiflow Nasal Oxygen Cannula with CO2 Sampling Fisher & Paykel Healthcare, Ltd., NZ | BTT |
| Jun 2, 2020 | K200089 | F&P Evora Nasal Mask Nasal A Model (Small, Medium, Large, Wide), F&P Evora Nasal Mask Nasal Fit Pack/ SML (Small/Medium/ Fisher & Paykel Healthcare, Ltd., NZ | BZD |
| Mar 19, 2020 | K191818 | F&P Optiflow 3S Nasal Cannula (Small, Medium, Large) Fisher & Paykel Healthcare, Ltd., NZ | BTT |
| Mar 9, 2020 | K191624 | F&P Nivairo RT047 Vented Hospital Full Face Mask, Anti-Asphyxiation Valve Version Fisher & Paykel Healthcare Limited, NZ | MNT |
| Oct 11, 2019 | K190713 | F&P Vitera Mask Full Face A Model (Small, Medium, Large), F&P Vitera Mask Full Face Sleep Lab Model (Small, Medium, Larg Fisher & Paykel Healthcare, Ltd., NZ | BZD |
| Apr 5, 2019 | K173770 | OJR215 Pressure Relief Manifold Fisher & Paykel Healthcare Limited, NZ | CBP |
| Dec 20, 2018 | K162553 | AirSpiral Heated Breathing Tube Fisher & Paykel Healthcare, NZ | BTT |
| Aug 8, 2018 | K173193 | F&P SleepStyle Fisher & Paykel Healthcare, Ltd., NZ | BZD |
| Jun 23, 2017 | K162582 | HumiGard Surgical Humidification System, HumiGard Humdified Insufflation Kit Fisher & Paykel Healthcare, NZ | HIF |
| Jan 24, 2017 | K161686 | F&P InfoSmart Fisher & Paykel Healthcare, Ltd., NZ | BZD |
| Jan 18, 2017 | K161412 | F&P Brevida Nasal Pillows Mask Fisher & Paykel Healthcare, Ltd., NZ | BZD |
| Sep 20, 2016 | K153505 | F&P Eson 2 Nasal Mask Fisher & Paykel Healthcare Limited, NZ | BZD |
| Mar 5, 2015 | K143646 | MR810 System, 900MR810 Adult Single Limb Circuit, 900MR810E Adult Dual Limb Circuit Fisher & Paykel Healthcare, Ltd., NZ | BTT |
| Mar 25, 2014 | K132017 | HC550 RESPIRATORY HUMIDIFIER, ADULT VENTILATOR CIRCUIT Fisher & Paykel Healthcare, Ltd., NZ | BTT |
| Feb 5, 2014 | K133666 | RT016 INSPIRATORY FILTER Fisher & Paykel Healthcare, Ltd., NZ | CAH |
| Dec 4, 2013 | K131957 | MR810RESPIRATORY HUMIDIFIER, 900MR810 ADULT SINGLE LIMB CIRCUIT, 900MR810E ADULT DUAL LIMB CIRCUIT Fisher & Paykel Healthcare, Ltd., NZ | BTT |
| Oct 24, 2013 | K131895 | AIRVO 2 HUMIDIFIER, MYAIRVO 2 HUMIDIFIER Fisher & Paykel Healthcare, Ltd., NZ | BTT |
| Jun 5, 2013 | K130328 | F&P SIMPLUS FULL FACE MASK Fisher & Paykel Healthcare Limited, NZ | BZD |
| Jan 3, 2013 | K121975 | AIRVO HUMIDIFIER MYAIRO HUMIDIFIER Fisher & Paykel Healthcare, Ltd., NZ | BTT |
| Dec 6, 2012 | K122432 | ADULT EVAQUA 2' DUAL HEATED BREATHING CIRCUITS Fisher & Paykel Healthcare, Ltd., NZ | BZE |
| Oct 2, 2012 | K121597 | ESON NASAL MASK Fisher & Paykel Healthcare Limited, NZ | BZD |
| Apr 16, 2012 | K103767 | DUAL HEATED INFANT VREATHING CIROUITS Fisher & Paykel Healthcare, Ltd., NZ | BZE |
| Mar 30, 2012 | K110019 | RESPIRATORY HUMIDIFER Fisher & Paykel Healthcare, Ltd., NZ | BTT |
| Feb 23, 2012 | K120027 | PILAIRO NASAL PILLOWS MASK Fisher & Paykel Healthcare Limited, NZ | BZD |
| Aug 19, 2011 | K110316 | INFOSEND GSM Fisher & Paykel Healthcare, Ltd., NZ | BZD |
| Mar 24, 2011 | K103786 | ZEST PETITE NASAL MASK Fisher & Paykel Healthcare, Ltd., NZ | BZD |
| Oct 8, 2010 | K100011 | FISHER & PAYKEL HEALTHCARE BUBBLE CPAP SYSTEM Fisher & Paykel Healthcare, Ltd., NZ | BZD |
Newest 50 of 83.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 15, 2025 | Fisher & Paykel Healthcare, Ltd. Airvo 2, REF: PT101US, and myAirvo 2, REF: PT100US, used with Disinfection Kit User Manual, REF: UI-185043723 Open, Classified |
BTT | K131895 |
| Sep 25, 2024 | Fisher & Paykel Healthcare, Ltd. PT301US Airvo 3 Respiratory Support Device
with software version 1.2.0 and/or 1.5.1
The Airvo 3 is intended to provide high flow warmed and humidified respiratory gases for administration to spontane Open, Classified |
QAV | K221338 |
| May 15, 2024 | Fisher & Paykel Healthcare, Ltd. Airvo 2 Humidifier, REF: PT101US, and myAirvo 2 Humidifier, REF: PT100US Open, Classified |
BTT | K131895 |
| Nov 13, 2014 | Fisher & Paykel Healthcare, Ltd. Fisher and Paykel Healthcare (FPH) IW900-Series Infant Warmer
Fisher and Paykel; Healthcare CosyCot and Kit Replacement Head Case Assembly
It is designed to assist with the thermoregulation of infan Terminated |
FMT | K970432 K971461 |
| May 20, 2014 | Fisher & Paykel Healthcare, Ltd. Infant Nasal CPAP (continuous positive airway pressure) Prong, Nasal.
CPAP Prongs (10 pack):
Model No. BC3020-10, BC3520-10, BC4030-10, BC4540-10, BC5040-10, BC5050-10, BC5550-10, BC5560-10, BC6060-1 Terminated |
BZO | None listed |
| May 30, 2013 | Fisher & Paykel Healthcare, Ltd. Fisher & Paykel Healthcare ICON CPAP (continuous positive airway pressure).
Models:
ICON Auto: ICONAAN, ICONAAN-HT, ICONAAJ.
ICON Novo: ICONNAN, ICONNAN-HT, ICONNAJ.
ICON Premo: ICONPBN, ICONPB Terminated |
BZD | K094040 |
| Jan 3, 2013 | Fisher & Paykel Healthcare, Ltd. Fisher & Paykel Healthcare reusable breathing circuit.
Non-heated breathing circuit, 1.8m or 6 feet in length.
Oxygen therapy delivery system for adult patient. Terminated |
BZO | None listed |
| Dec 10, 2008 | Fisher & Paykel Healthcare Inc Fisher & Paykel Healthcare RT240 Adult Breathing Circuit Kit.
lntended Use: The dual heated adult respiratory ventilator circuits are intended as conduits of breathing gas for ventilation of patien Terminated |
BTT | K983112 |
| Jun 27, 2007 | Fisher & Paykel Healthcare Inc Fisher & Paykel Spares CPAP Mask and Connectors, Part Numbers: 400HC202 (Elbow non-diffuser holes),400HC203 (Elbow + vent NR valve), 400HC209 (Oracle 452 flexitube kit vent NR), 400HC502 (HC407 mask n Terminated |
BZD | K003894 K033087 +1 |
| Jun 27, 2007 | Fisher & Paykel Healthcare Inc Fisher & Paykel Oracle Oral Mask, Part Numbers: 900HC451, 900HC451T, HC451A, HC452A & HC452F. CPAP masks. Terminated |
BZD | K003894 K033087 +1 |
| Jun 27, 2007 | Fisher & Paykel Healthcare Inc Fisher & Paykel Infinity Direct Nasal Mask, Part Numbers: HC481A & HC481SL. CPAP masks. Terminated |
BZD | K003894 K033087 +1 |
| Jun 27, 2007 | Fisher & Paykel Healthcare Inc Fisher & Paykel FlexiFix Nasal Mask, Part Numbers: HC405A, HC405SL, HC405U, HCHC406A, HC406SL, HC407A, HC407SL & HC407U. CPAP masks. Terminated |
BZD | K003894 K033087 +1 |
| Jun 27, 2007 | Fisher & Paykel Healthcare Inc Fisher & Paykel Aclaim Nasal Mask, Part Numbers: HC401A & 900HC401. CPAP masks. Terminated |
BZD | K003894 K033087 +1 |
| Jun 27, 2007 | Fisher & Paykel Healthcare Inc Fisher & Paykel FlexiFit Full Face Mask, Part Numbers: HC 431A, HC431SLL, HC431SLM & HC431SLS. CPAP masks. Terminated |
BZD | K003894 K033087 +1 |
| Jan 11, 2007 | Fisher & Paykel Healthcare Ltd Fisher & Paykel IW930 CosyCot Infant Radiant Warmer (with integrated bed) fitted with 9001W005J Elevator Module Terminated |
FMT | K970432 |
| Mar 29, 2006 | Fisher & Paykel Healthcare Inc Fisher & Paykel Healthcare Adult Respiratory Ventilator Circuit-Dual Heated Catalogue Number RT211 Terminated |
BTT | K983112 |
| Mar 29, 2006 | Fisher & Paykel Healthcare Inc Fisher & Paykel Healthcare Adult Respiratory Ventilator Circuit-Dual Heated Catalogue Number RT210 Terminated |
BTT | K983112 |
| Mar 29, 2006 | Fisher & Paykel Healthcare Inc Fisher & Paykel Healthcare Adult Respiratory Ventilator Circuit-Dual Heated Catalogue Number RT111 Terminated |
BTT | K983112 |
| Mar 29, 2006 | Fisher & Paykel Healthcare Inc Fisher & Paykel Healthcare Adult Respiratory Ventilator Circuit-Dual Heated Catalogue Number RT110 Terminated |
BTT | K983112 |
| Feb 18, 2005 | Fisher & Paykel Healthcare Inc RT130 and RT131 Neonatal/ Infant Breathing Circuits, heated wire. For use with MR850 Respiratory Humidifier. Terminated |
BTT | K020332 |
| Dec 18, 2003 | Fisher & Paykel Healthcare Inc Phototherapy Lamp, Model 9001W501JE Terminated |
LBI | None listed |