Fisher & Paykel Healthcare Limited: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Fisher & Paykel Healthcare Limited” (first 2012, latest 2025), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 207 days. Since 2017 the median was 238 days, against 231 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 | 2 | 88 |
| 2013 | 1 | 114 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 1 | 288 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 1 | 480 |
| 2020 | 1 | 265 |
| 2021 | 1 | 204 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 1 | 210 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Fisher & Paykel Healthcare Limited took a median 238 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 231 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| BZD | Ventilator, Non-Continuous (Respirator) | 5 | 5 |
| CAF | Nebulizer (Direct Patient Interface) | 1 | 1 |
| CBP | Valve, Non-Rebreathing | 1 | 1 |
| MNT | Sv70 Ventilator | 1 | 1 |
Review panels
- Anesthesiology (8)
Most recent Fisher & Paykel Healthcare Limited 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K243583 | F&P Nova Nasal Mask | BZD | 2025-06-18 | 210 |
| K211560 | Airvo Nebulizer Adapter | CAF | 2021-12-10 | 204 |
| K191624 | F&P Nivairo RT047 Vented Hospital Full Face Mask, Anti-Asphyxiation Valve Version | MNT | 2020-03-09 | 265 |
| K173770 | OJR215 Pressure Relief Manifold | CBP | 2019-04-05 | 480 |
| K153505 | F&P Eson 2 Nasal Mask | BZD | 2016-09-20 | 288 |
| K130328 | F&P SIMPLUS FULL FACE MASK | BZD | 2013-06-05 | 114 |
| K121597 | ESON NASAL MASK | BZD | 2012-10-02 | 124 |
| K120027 | PILAIRO NASAL PILLOWS MASK | BZD | 2012-02-23 | 51 |
Recalls
openFDA lists no recalls under a recalling firm named Fisher & Paykel Healthcare Limited.
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 Limited (a text match, not an official crosswalk):
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 Healthcare, Ltd. (75 510(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 and Paykel Healthcare Limited (4 510(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 Limited?
FDA lists 8 510(k) clearances under the applicant name “Fisher & Paykel Healthcare Limited” (first 2012, latest 2025), across 4 product codes in 1 review panel. 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 Limited?
The median time from FDA receipt to decision across 510(k)s cleared under the name Fisher & Paykel Healthcare Limited is 207 days. Since 2017: 238 days, versus 231 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Fisher & Paykel Healthcare Limited?
The most frequent FDA product codes under this applicant name are BZD (Ventilator, Non-Continuous (Respirator), 5); CAF (Nebulizer (Direct Patient Interface), 1); CBP (Valve, Non-Rebreathing, 1).
Next steps
- See all 8 Fisher & Paykel Healthcare Limited clearances with predicates and recalls
- Run predicate analysis for product code BZD, Fisher & Paykel Healthcare Limited'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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.