Fisher & Paykel Healthcare, Ltd.: FDA filings under this applicant name
FDA lists 82 510(k) clearances under 3 spellings of the applicant name “Fisher & Paykel Healthcare, Ltd.” (first 1988, latest 2026), across 14 product codes in 3 review panels. Median 510(k) review time under this name: 186 days. Since 2017 the median was 230 days, against 236 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 5 | 124 |
| 2013 | 4 | 140 |
| 2014 | 2 | 168 |
| 2015 | 1 | 73 |
| 2016 | 1 | 288 |
| 2017 | 3 | 221 |
| 2018 | 2 | 214 |
| 2019 | 2 | 343 |
| 2020 | 3 | 258 |
| 2021 | 3 | 204 |
| 2022 | 3 | 290 |
| 2023 | 4 | 264 |
| 2024 | 6 | 230 |
| 2025 | 6 | 136 |
| 2026 | 1 | 52 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Fisher & Paykel Healthcare, Ltd. took a median 230 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 236 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| BZD | Ventilator, Non-Continuous (Respirator) | 31 | 31 |
| BTT | Humidifier, Respiratory Gas, (Direct Patient Interface) | 26 | 26 |
| CBK | Ventilator, Continuous, Facility Use | 4 | 4 |
| MNT | Sv70 Ventilator | 4 | 4 |
| BZE | Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer | 3 | 3 |
| CAH | Filter, Bacterial, Breathing-Circuit | 3 | 3 |
| CBP | Valve, Non-Rebreathing | 3 | 3 |
| ILY | Lamp, Infrared, Therapeutic Heating | 2 | 2 |
| BXN | Stimulator, Nerve, Battery-Powered | 1 | 1 |
| BZR | Mixer, Breathing Gases, Anesthesia Inhalation | 1 | 1 |
Plus 4 more product codes.
Review panels
- Anesthesiology (76)
- General Hospital (4)
- Physical Medicine (2)
Most recent Fisher & Paykel Healthcare, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K262268 | Optiflow Oxygen Kit (AA484J) | BTT | 2026-08-27 | 52 |
| K253479 | Optiflow Switch+ Filtered Nasal Interface with CO2 Sampling (AA042J) | BTT | 2025-12-19 | 66 |
| 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 | 2025-11-19 | 260 |
| 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 | 2025-09-10 | 61 |
| K243917 | F&P Optiflow Air/Oxygen Flow Source | BZR | 2025-07-14 | 206 |
| 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 | 2025-06-25 | 29 |
| K243583 | F&P Nova Nasal Mask | BZD | 2025-06-18 | 210 |
| 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 | 2024-08-23 | 266 |
| K234053 | F&P Optiflow Flow Diverter | CBP | 2024-08-09 | 231 |
| K233643 | F&P Airvo 3 NIV (PT311US) | MNT | 2024-08-09 | 270 |
72 earlier clearances. See the full list in Caduvo.
Recalls
8 product recalls in 8 recall events; 3 initiated in the last five years. Most recent: 2025-09-18.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Fisher & Paykel Healthcare, Ltd. (a text match, not an official crosswalk):
FDA spellings included
FDA records this applicant under 3 spellings (case, punctuation and legal-suffix variants of one name); this page adds them up. Filings per spelling:
- Fisher & Paykel Healthcare, Ltd. (70)
- Fisher & Paykel Healthcare Limited (8)
- Fisher and Paykel Healthcare Limited (4)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Fisher Scientific Co., LLC (89 510(k)s)
- Fisher & Paykel Electronics , Ltd. (17 510(k)s)
- Fisher Diagnostics (16 510(k)s)
- Fisher & Paykel Allied Products , Ltd. (12 510(k)s)
- Fisher & Paykel Healthcare (5 510(k)s)
- Fisher Imaging Corp. (3 510(k)s)
- Fisher Price (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Fisher & Paykel Healthcare, Ltd.?
FDA lists 82 510(k) clearances under 3 spellings of the applicant name “Fisher & Paykel Healthcare, Ltd.” (first 1988, latest 2026), across 14 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Fisher & Paykel Healthcare, Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Fisher & Paykel Healthcare, Ltd. is 186 days. Since 2017: 230 days, versus 236 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Fisher & Paykel Healthcare, Ltd.?
The most frequent FDA product codes under this applicant name are BZD (Ventilator, Non-Continuous (Respirator), 31); BTT (Humidifier, Respiratory Gas, (Direct Patient Interface), 26); CBK (Ventilator, Continuous, Facility Use, 4).
Next steps
- See all 82 Fisher & Paykel Healthcare, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code BZD, Fisher & Paykel Healthcare, Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.