Fisher & Paykel Healthcare, Inc.
Irvine, CA, US
FISHER & PAYKEL HEALTHCARE, INC. appears in FDA device records in Irvine, CA. FDA records list 86 510(k) clearances between and , no PMA records and 4 registered establishments. As of , FDA records show 21 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
Showing 50 of 86FDA records hold 86 510(k) clearances for Fisher & Paykel Healthcare, Inc. between 1988 and 2025. The busiest year on record is 2024, with 7. The most recent is 2025, with 6.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1988 | 1 |
| 1989 | 1 |
| 1996 | 1 |
| 1998 | 2 |
| 2000 | 1 |
| 2001 | 3 |
| 2003 | 4 |
| 2004 | 6 |
| 2005 | 3 |
| 2006 | 3 |
| 2008 | 3 |
| 2009 | 2 |
| 2010 | 4 |
| 2011 | 2 |
| 2012 | 5 |
| 2013 | 4 |
| 2014 | 2 |
| 2015 | 1 |
| 2016 | 1 |
| 2017 | 4 |
| 2018 | 3 |
| 2019 | 2 |
| 2020 | 3 |
| 2021 | 3 |
| 2022 | 3 |
| 2023 | 6 |
| 2024 | 7 |
| 2025 | 6 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K253479 | Optiflow Switch+ Filtered Nasal Interface with CO2 Sampling (AA042J) | BTT | Substantially Equivalent | |
| 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 | Substantially Equivalent | |
| 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 | Substantially Equivalent | |
| K243917 | F&P Optiflow Air/Oxygen Flow Source | BZR | Substantially Equivalent | |
| 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 | Substantially Equivalent | |
| K243583 | F&P Nova Nasal Mask | BZD | Substantially Equivalent | |
| K233829 | Nova Micro Pillows Mask Small A Model (NVP1SA); Nova Micro Pillows Mask Medium A Model (NVP1MA); Nova Micro Pillows Mask Large A Model (NVP1LA); Nova Micro Pillows Mask Fit Pack/SML A Model (NVP1SMLA); Nova Micro Pillows Mask Small Sleep Lab A (NVP1SSLA); Nova Micro Pillows Mask Medium Sleep Lab A (NVP1MSLA); Nova Micro Pillows Mask Large Sleep Lab A (NVP1LSLA); Nova Micro Pillows Mask Fit Pack Sleep Lab A (NVP1SMLSLA) | BZD | Substantially Equivalent | |
| K234053 | F&P Optiflow Flow Diverter | CBP | Substantially Equivalent | |
| K233643 | F&P Airvo 3 NIV (PT311US) | MNT | Substantially Equivalent | |
| K234058 | F&P Optiflow Filtered Nasal Interface with Anesthesia Mask Compatibility (AA041J) | BTT | Substantially Equivalent | |
| K233821 | F&P Optiflow Oxygen Kit (AA451J) | BTT | Substantially Equivalent | |
| K222292 | F&P myAirvo 3 | BTT | Substantially Equivalent | |
| K231956 | F&P Optiflow+ Duet Nasal Cannula | BTT | Substantially Equivalent | |
| K223684 | F&P 820 Humidification System | BTT | Substantially Equivalent | |
| K221436 | F&P 950 Accessory Breathing Circuit Kits | BZD | Substantially Equivalent | |
| K220703 | F&P 950 Respiratory Humidifier | BTT | Substantially Equivalent | |
| K223696 | F&P Solo Mask Range | BZD | Substantially Equivalent | |
| K222197 | F&P Optiflow Junior 2/2+ Nasal Cannula Interface Range | BTT | Substantially Equivalent | |
| K221338 | F&P Airvo 3 | QAV | Substantially Equivalent | |
| K212031 | F&P 850 AirSpiral Adult NIV and NHF Circuit Kit | BTT | Substantially Equivalent | |
| K212371 | F&P Evora Full Face Mask | BZD | Substantially Equivalent | |
| K211096 | Optiflow Oxygen Kit | BTT | Substantially Equivalent | |
| K211560 | Airvo Nebulizer Adapter | CAF | Substantially Equivalent | |
| K203449 | F&P Visairo NIV Mask Range | CBK | Substantially Equivalent | |
| K201723 | F&P Optiflow Nasal Oxygen Cannula with CO2 Sampling | BTT | Substantially Equivalent | |
| 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 | Substantially Equivalent | |
| K191818 | F&P Optiflow 3S Nasal Cannula (Small, Medium, Large) | BTT | Substantially Equivalent | |
| K191624 | F&P Nivairo RT047 Vented Hospital Full Face Mask, Anti-Asphyxiation Valve Version | MNT | Substantially Equivalent | |
| K190713 | F&P Vitera Mask Full Face A Model (Small, Medium, Large), F&P Vitera Mask Full Face Sleep Lab Model (Small, Medium, Large) | BZD | Substantially Equivalent | |
| K173770 | OJR215 Pressure Relief Manifold | CBP | Substantially Equivalent | |
| K162553 | AirSpiral Heated Breathing Tube | BTT | Substantially Equivalent | |
| K173193 | F&P SleepStyle | BZD | Substantially Equivalent | |
| K173060 | F&P NivairoTM RT046 Non-Vented Hospital Full Face Mask, Standard Elbow Version | CBK | Substantially Equivalent | |
| K170367 | Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Large, Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Medium, Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Small, Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Extra Small | MNT | Substantially Equivalent | |
| K162582 | HumiGard Surgical Humidification System, HumiGard Humdified Insufflation Kit | HIF | Substantially Equivalent | |
| K161686 | F&P InfoSmart | BZD | Substantially Equivalent | |
| K161412 | F&P Brevida™ Nasal Pillows Mask | BZD | Substantially Equivalent | |
| K153505 | F&P Eson 2 Nasal Mask | BZD | Substantially Equivalent | |
| K143646 | MR810 System, 900MR810 Adult Single Limb Circuit, 900MR810E Adult Dual Limb Circuit | BTT | Substantially Equivalent | |
| K132017 | HC550 RESPIRATORY HUMIDIFIER, ADULT VENTILATOR CIRCUIT | BTT | Substantially Equivalent | |
| K133666 | RT016 INSPIRATORY FILTER | CAH | Substantially Equivalent | |
| K131957 | MR810RESPIRATORY HUMIDIFIER, 900MR810 ADULT SINGLE LIMB CIRCUIT, 900MR810E ADULT DUAL LIMB CIRCUIT | BTT | Substantially Equivalent | |
| K131895 | AIRVO 2 HUMIDIFIER, MYAIRVO 2 HUMIDIFIER | BTT | Substantially Equivalent | |
| K130328 | F&P SIMPLUS FULL FACE MASK | BZD | Substantially Equivalent | |
| K121975 | AIRVO HUMIDIFIER MYAIRO HUMIDIFIER | BTT | Substantially Equivalent | |
| K122432 | ADULT EVAQUA 2' DUAL HEATED BREATHING CIRCUITS | BZE | Substantially Equivalent | |
| K121597 | ESON NASAL MASK | BZD | Substantially Equivalent | |
| K103767 | DUAL HEATED INFANT VREATHING CIROUITS | BZE | Substantially Equivalent | |
| K110019 | RESPIRATORY HUMIDIFER | BTT | Substantially Equivalent | |
| K120027 | PILAIRO NASAL PILLOWS MASK | BZD | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2085602 | 3000210616 | FISHER & PAYKEL HEALTHCARE, INC. | 17400 Laguna Canyon Road, IRVINE, CA 92618 US | 2026 | and 26 more, listed in full below |
| 3005372462 | 3005372462 | FISHER & PAYKEL HEALTHCARE, INC. | 3201 South Park Road, Louisville, KY 40219 US | 2026 | No device listings on this registration |
| 9611451 | 3002806988 | FISHER & PAYKEL HEALTHCARE, LTD. | 15 MAURICE PAYKEL PLACE, EAST TAMAKI Auckland 2013 NZ | 2026 | and 26 more, listed in full below |
| 3031126394 | 3031126394 | Fisher & Paykel Healthcare, INC. | 511 Harley Knox Blvd, Perris, CA 92571 US | 2026 | No device listings on this registration |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KMEBedding, Disposable, Medical
- CATCannula, Nasal, Oxygen
- CAICircuit, Breathing (W Connector, Adaptor, Y Piece)
- BZAConnector, Airway (Extension)
- MNTContinuous, Minimal Ventilatory Support, Facility Use Ventilator
- BYHDrain, Tee (Water Trap)
- CAHFilter, Bacterial, Breathing-Circuit
- CAXFlowmeter, Tube, Thorpe, Back-Pressure Compensated
- BXHGauge, Gas Pressure, Cylinder/Pipeline
- CAWGenerator, Oxygen, Portable
- BZEHeater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
- QAVHigh Flow/High Velocity Humidified Oxygen Delivery Device
- BTTHumidifier, Respiratory Gas, (Direct Patient Interface)
- HIFInsufflator, Laparoscopic
- ILYLamp, Infrared, Therapeutic Heating
- BYGMask, Oxygen
- BYFMask, Oxygen, Low Concentration, Venturi
- OUGMedical Device Data System
- BZRMixer, Breathing Gases, Anesthesia Inhalation
- CAFNebulizer (Direct Patient Interface)
- SGRNoninvasive Positive Airway Pressure System, Facility Use
- CANRegulator, Pressure, Gas Cylinder
- KDPRegulator, Vacuum
- FRWScale, Patient
- BZOSet, Tubing And Support, Ventilator (W Harness)
- FOXStand, Infusion
- BXNStimulator, Nerve, Battery-Powered
- KOIStimulator, Nerve, Peripheral, Electric
- JAYSupport, Breathing Tube
- KGXTape And Bandage, Adhesive
- BYXTubing, Pressure And Accessories
- LBIUnit, Neonatal Phototherapy
- CBPValve, Non-Rebreathing
- CBKVentilator, Continuous, Facility Use
- BTLVentilator, Emergency, Powered (Resuscitator)
- BZDVentilator, Non-Continuous (Respirator)
- FMTWarmer, Infant Radiant
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| 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 alert for less than 120 seconds, which may delay user awareness to reconnect power, which could lead to oxygen desaturation, hypoxia. Disinfection kit user manual updated to include checking the audible alert prior to use on a new patient. | Class II | Open, Classified | |
| 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 provide high flow warmed and humidified respiratory gases for administration to spontaneously breathing infant, child, adolescent and adult patients in hospitals and sub-acute facilities. | 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 only. If this happens, a patient my experience oxygen desaturation that could lead to hypoxia. | Class II | Open, Classified | |
| 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 in distorted, intermittent or inaudible alarm sound levels. In the absence of an audible alarm, if there is an interruption to therapy, a patient may experience oxygen desaturation. | Class II | Open, Classified | |
| Z-0210-2015 | 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 infants weighing up to 10kg and is used by labor and delivery rooms and pediatric intensive care units. Infant Warmers Model Number (REF) IW910XXX, IW920XXX, IW931XXX, IW932XXX, IW933XXX, IW934XXX, IW951XXX, IW952XXX, IW953XXX, IW954XXX, IW980XXX, IW990XXX Spare Parts Model Number (REF) 043041129, 043041130, 043041131, 043042359, 648040142 | Breakage of the nut that secures the heater head in place, which can cause the heater head to become partially detached and swing towards the bassinet. There is the potential that a heater head could contact a patient situated on the bassinet and cause a serious injury. | Class II | Terminated | |
| Z-1539-2014 | 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, BC6060-10, BC6070-10, BC6570-10. Bubble CPAP Starter Kits: Model No. BC461-SK, BC471-SK, BC490-SK, BC491-SK, BC492-SK. The Nasal CPAP Prongs connect to the FPH FlexiTrunk Patient Interface. | The Infant Nasal CPAP Prong has the potential to detach from the Nasal Tubing and therapy is likely to be interrupted. | Class I | Terminated | |
| Z-1437-2013 | 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, ICONPBN-HT, ICONPBN-HTC. The ICON CPAP unit is for use on adult patients for the treatment of Obstructive Sleep Apnea (OSA). The device is for use in the home or sleep laboratory. The device is not intended to be used as a life supporting device. | Fisher and Paykel Healthcare is recalling the ICON CPAP units because there is a potential power issue on certain ICON CPAP. These ICON CPAP units could potentially become inoperable, which would result in a lack of treatment to the patient's obstructive sleep apnea symptoms until a replacement unit is obtained. | Class II | Terminated | |
| Z-0621-2013 | Fisher & Paykel Healthcare reusable breathing circuit. Non-heated breathing circuit, 1.8m or 6 feet in length. Oxygen therapy delivery system for adult patient. | FPH has become aware that one batch of tubes supplied to FPH may contain hole damage. These tubes were incorporated by FPH into certain 900MR068 reusable circuits with lot numbers 110810 and 111020. If this hole damage is not detected during the standard leak test before patient use, it could potentially result in a gas leak in the breathing system, which may lead to a loss of pressure for the int | Class I | Terminated | |
| Z-0414-2009 | 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 patients, and to maintain the temperature of the humidified gas, to reduce condensation. | The recall was initiated because certain lot dates of the RT240 Adult Breathing Circuit Kits manufactured on or before June 27, 2008 include a heated breathing circuit that may be more susceptible to damage when used in excess of the specified seven-day maximum duration of use, which may increase the risk of malfunction or fire. | Terminated | ||
| Z-0974-2007 | 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 no headgear), 400HC503 (HC431 mask no headgear), 400HC505 (Infinity HC481 mask base), 400HCHC510 (HC406 mask no headgear) , 900HC402 (Aclaim mask no headgear), 900HC405 (HC405 sleep lab mask kit), 900HC406 (HC405 mask no headgear), 900HC412 (Aclaim flexitube kit), 900HC441 (Elbow diffuser and swivel) & 900HC463 (HC451 flexitube kit). CPAP masks. | Plastic tabs incorporated into the connector components of these CPAP masks may break off if they are not cleaned in accordance with the Instructions for Use. In the event of a tab breaking off, it may enter the CPAP system air path and there is an extremely remote possibility that the broken tab may then enter the patient's nasal cavity or mouth. Masks manufactured since April 2006 do not feat | Terminated | ||
| Z-0973-2007 | Fisher & Paykel Oracle Oral Mask, Part Numbers: 900HC451, 900HC451T, HC451A, HC452A & HC452F. CPAP masks. | Plastic tabs incorporated into the connector components of these CPAP masks may break off if they are not cleaned in accordance with the Instructions for Use. In the event of a tab breaking off, it may enter the CPAP system air path and there is an extremely remote possibility that the broken tab may then enter the patient's nasal cavity or mouth. Masks manufactured since April 2006 do not feat | Terminated | ||
| Z-0972-2007 | Fisher & Paykel Infinity Direct Nasal Mask, Part Numbers: HC481A & HC481SL. CPAP masks. | Plastic tabs incorporated into the connector components of these CPAP masks may break off if they are not cleaned in accordance with the Instructions for Use. In the event of a tab breaking off, it may enter the CPAP system air path and there is an extremely remote possibility that the broken tab may then enter the patient's nasal cavity or mouth. Masks manufactured since April 2006 do not feat | Terminated | ||
| Z-0971-2007 | Fisher & Paykel FlexiFix Nasal Mask, Part Numbers: HC405A, HC405SL, HC405U, HCHC406A, HC406SL, HC407A, HC407SL & HC407U. CPAP masks. | Plastic tabs incorporated into the connector components of these CPAP masks may break off if they are not cleaned in accordance with the Instructions for Use. In the event of a tab breaking off, it may enter the CPAP system air path and there is an extremely remote possibility that the broken tab may then enter the patient's nasal cavity or mouth. Masks manufactured since April 2006 do not feat | Terminated | ||
| Z-0970-2007 | Fisher & Paykel Aclaim Nasal Mask, Part Numbers: HC401A & 900HC401. CPAP masks. | Plastic tabs incorporated into the connector components of these CPAP masks may break off if they are not cleaned in accordance with the Instructions for Use. In the event of a tab breaking off, it may enter the CPAP system air path and there is an extremely remote possibility that the broken tab may then enter the patient's nasal cavity or mouth. Masks manufactured since April 2006 do not feat | Terminated | ||
| Z-0969-2007 | Fisher & Paykel FlexiFit Full Face Mask, Part Numbers: HC 431A, HC431SLL, HC431SLM & HC431SLS. CPAP masks. | Plastic tabs incorporated into the connector components of these CPAP masks may break off if they are not cleaned in accordance with the Instructions for Use. In the event of a tab breaking off, it may enter the CPAP system air path and there is an extremely remote possibility that the broken tab may then enter the patient's nasal cavity or mouth. Masks manufactured since April 2006 do not featu | Terminated | ||
| Z-0485-2007 | Fisher & Paykel IW930 CosyCot Infant Radiant Warmer (with integrated bed) fitted with 9001W005J Elevator Module | This firm has received Product Complaint Reports concerning bending of the pivot plate. The elevator base of the CosyCot Infant Warmer incorporates a pivot plate which forms part of the mechanism allowing the CosyCot to raise and lower in height. A bent pivot plate generally results in the Warmer being unable to elevate properly. Other component failures may result. | Terminated | ||
| Z-0697-06 | Fisher & Paykel Healthcare Adult Respiratory Ventilator Circuit-Dual Heated Catalogue Number RT211 | Risk of fire. The manufacturing process may have the potential to damage the insulation of the heater wire in circuits within the specified lot range. This may lead to a potential risk of fire. | Terminated | ||
| Z-0696-06 | Fisher & Paykel Healthcare Adult Respiratory Ventilator Circuit-Dual Heated Catalogue Number RT210 | Risk of fire. The manufacturing process may have the potential to damage the insulation of the heater wire in circuits within the specified lot range. This may lead to a potential risk of fire. | Terminated | ||
| Z-0695-06 | Fisher & Paykel Healthcare Adult Respiratory Ventilator Circuit-Dual Heated Catalogue Number RT111 | Risk of fire. The manufacturing process may have the potential to damage the insulation of the heater wire in circuits within the specified lot range. This may lead to a potential risk of fire. | Terminated | ||
| Z-0694-06 | Fisher & Paykel Healthcare Adult Respiratory Ventilator Circuit-Dual Heated Catalogue Number RT110 | Risk of fire. The manufacturing process may have the potential to damage the insulation of the heater wire in circuits within the specified lot range. This may lead to a potential risk of fire. | Terminated | ||
| Z-0553-05 | RT130 and RT131 Neonatal/ Infant Breathing Circuits, heated wire. For use with MR850 Respiratory Humidifier. | Pressure elbow may be partly occluded. | Terminated | ||
| Z-0241-04 | Phototherapy Lamp, Model 9001W501JE | Component placement presents risk of electrocution to patients. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain