FISHER & PAYKEL HEALTHCARE, INC.
Registration 2085602FEI 3000210616IRVINE, CA
Owner/operator: FISHER & PAYKEL HEALTHCARE NZ LTD
- Complaint File Establishment per 21 CFR 820.198
Renewal due by December 31, 2026
Registered through 2026. Renew between October 1 and December 31, 2026, to stay registered for 2027.
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The 2026 window
- Oct 1Window opens91 days left
- Nov 3Where you stand58 days left
- Dec 1Our pay-by date30 days left
- Dec 15Two weeks left16 days left
- Dec 23Holiday week8 days left
- Dec 29Two days left2 days left
- Dec 31Window closes0 days left
- FDA fee, FY2027
- $13,785
- Our pay-by suggestion
- Dec 1
- Listed devices
- 114
- Added, last 12 months
- 5
FDA sets who pays the fee and who may qualify for a waiver; its fee page says so. The fee is paid only on FDA’s own fee site. Never through us. FDA’s fee page
The steps, in order
Pay FDA's annual feeYou
Order and pay the FY2027 establishment fee on FDA's Device Facility User Fee site. FDA emails you a PIN when you order.
FDA: registration and listing payment processWait for the payment confirmation numberYou
FDA emails a Payment Confirmation Number (PCN) once the payment processes, which FDA says typically takes several days. That is why we suggest paying by December 1.
FDA: registration and listing payment processRenew the registration in FDA's systemYou
Sign in to FDA's Unified Registration and Listing System (FURLS), complete the annual registration and apply your PIN and PCN. FDA does not count the registration as complete until both are applied.
FDA: device registration and listingReview every listingYou
In the same window, review each listing on file and report any changes, deletions and new listings. Your Listing Review Sheet puts every listing on one page.
FDA: device registration and listing
Every listed device 114
| Code | Device | Class | Regulation | Premarket |
|---|---|---|---|---|
| CAH | Inspiratory/Expiratory FilterFilter, Bacterial, Breathing-Circuit | Class 2 | 21 CFR 868.5260 | K050927 |
| CAH | RT020 End Expiratory FilterFilter, Bacterial, Breathing-Circuit | Class 2 | 21 CFR 868.5260 | K002839 |
| CAH | RT016 FilterFilter, Bacterial, Breathing-Circuit | Class 2 | 21 CFR 868.5260 | K133666 |
| CAW | Waterfeed setGenerator, Oxygen, Portable | Class 2 | 21 CFR 868.5440 | K953949 |
| BZE | EvaquaHeater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer | Class 2 | 21 CFR 868.5270 | K034026 |
| BZE | Infant Evaqua 2 (RT265/RT266)Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer | Class 2 | 21 CFR 868.5270 | K103767 |
| BZE | RT232, 'Adult Optiflow Circuit Kit with MicroCell TechnologyHeater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer | Class 2 | 21 CFR 868.5270 | K122432 |
| QAV | Airvo 3High Flow/High Velocity Humidified Oxygen Delivery Device | Class 2 | 21 CFR 868.5454 | K221338 |
| BTT | MR410 Respiratory HumidifierHumidifier, Respiratory Gas, (Direct Patient Interface) | Class 2 | 21 CFR 868.5450 | K913367 |
| BTT | F&P Optiflow Nasal Oxygen Cannula with CO2 SamplingHumidifier, Respiratory Gas, (Direct Patient Interface) | Class 2 | 21 CFR 868.5450 | K201723 |
| BTT | MR290 Humidification ChamberHumidifier, Respiratory Gas, (Direct Patient Interface) | Class 2 | 21 CFR 868.5450 | K934140 |
| BTT | OptiflowHumidifier, Respiratory Gas, (Direct Patient Interface)Added Feb 10, 2026 | Class 2 | 21 CFR 868.5450 | K253479 |
and 102 more on your full dossier
What changed
- Feb 10, 2026Listing added: BTT — Optiflow (K253479)
- Sep 1, 2026Listing added: BTT — Optiflow Oxygen Kit (K262268)
- Nov 30, 2025Listing added: SGR — OptiPAP Junior (K250651)
- Nov 30, 2025Listing added: CBK — OptiNIV (K252173)
- Feb 9, 2026Listing added: BZD — F&P Nova Nasal (K243583)