Fisher & Paykel Healthcare, Ltd.: FDA clearances and approvals
Fisher & Paykel Healthcare, Ltd. has 75 FDA 510(k) clearances (first 1988, latest 2025), across 15 product codes in 4 review panels. Median 510(k) review time: 195 days. Since 2017 its median was 250 days, against 229 days for all cleared 510(k)s in the same product codes. openFDA lists 21 product recalls by a recalling firm named Fisher & Paykel Healthcare, Ltd.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 3 | 452 |
| 2013 | 3 | 160 |
| 2014 | 2 | 168 |
| 2015 | 1 | 73 |
| 2016 | 0 | — |
| 2017 | 3 | 243 |
| 2018 | 2 | 569 |
| 2019 | 1 | 206 |
| 2020 | 2 | 198 |
| 2021 | 2 | 204 |
| 2022 | 3 | 290 |
| 2023 | 6 | 267 |
| 2024 | 6 | 230 |
| 2025 | 5 | 66 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Fisher & Paykel Healthcare, Ltd.'s cleared 510(k)s took a median 250 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 229 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| BTT | Humidifier, Respiratory Gas, (Direct Patient Interface) | 28 | 28 |
| BZD | Ventilator, Non-Continuous (Respirator) | 25 | 25 |
| BZE | Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer | 3 | 3 |
| CAH | Filter, Bacterial, Breathing-Circuit | 3 | 3 |
| CBK | Ventilator, Continuous, Facility Use | 3 | 3 |
| CBP | Valve, Non-Rebreathing | 2 | 2 |
| ILY | Lamp, Infrared, Therapeutic Heating | 2 | 2 |
| MNT | Sv70 Ventilator | 2 | 2 |
| BXN | Stimulator, Nerve, Battery-Powered | 1 | 1 |
| BZR | Mixer, Breathing Gases, Anesthesia Inhalation | 1 | 1 |
Plus 5 more product codes.
Review panels
Most recent Fisher & Paykel Healthcare, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| 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 |
| K234053 | F&P Optiflow Flow Diverter | CBP | 2024-08-09 | 231 |
| K233643 | F&P Airvo 3 NIV (PT311US) | MNT | 2024-08-09 | 270 |
| K234058 | F&P Optiflow Filtered Nasal Interface with Anesthesia Mask Compatibility (AA041J) | BTT | 2024-08-08 | 230 |
| K233821 | F&P Optiflow Oxygen Kit (AA451J) | BTT | 2024-06-13 | 195 |
| K222292 | F&P myAirvo 3 | BTT | 2024-05-08 | 649 |
65 earlier clearances. See the full list in Caduvo.
Recalls
21 product recalls in 13 recall events; 3 initiated in the last five years. Most recent: 2025-09-18.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Fisher & Paykel Healthcare, Ltd. have?
Fisher & Paykel Healthcare, Ltd. has 75 FDA 510(k) clearances (first 1988, latest 2025), across 15 product codes in 4 review panels.
How long does FDA take to clear Fisher & Paykel Healthcare, Ltd.'s 510(k)s?
The median time from FDA receipt to decision across Fisher & Paykel Healthcare, Ltd.'s cleared 510(k)s is 195 days. Since 2017: 250 days, versus 229 days for all cleared 510(k)s in the same product codes.
What devices does Fisher & Paykel Healthcare, Ltd. make?
Its most frequent FDA product codes are BTT (Humidifier, Respiratory Gas, (Direct Patient Interface), 28); BZD (Ventilator, Non-Continuous (Respirator), 25); BZE (Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer, 3).
Has Fisher & Paykel Healthcare, Ltd. had device recalls?
openFDA lists 21 product recalls in 13 recall events by a recalling firm whose name matches Fisher & Paykel Healthcare, Ltd; the most recent began 2025-09-18. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 75 Fisher & Paykel Healthcare, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code BTT, Fisher & Paykel Healthcare, Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.