Fisher & Paykel Electronics , Ltd.: FDA filings under this applicant name
FDA lists 17 510(k) clearances under the applicant name “Fisher & Paykel Electronics , Ltd.” (first 1988, latest 1998), across 9 product codes in 2 review panels. Median 510(k) review time under this name: 170 days. 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 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| BTT | Humidifier, Respiratory Gas, (Direct Patient Interface) | 6 | 6 |
| FMT | Warmer, Infant Radiant | 4 | 4 |
| BTL | Ventilator, Emergency, Powered (Resuscitator) | 1 | 1 |
| BXN | Stimulator, Nerve, Battery-Powered | 1 | 1 |
| BZD | Ventilator, Non-Continuous (Respirator) | 1 | 1 |
| BZR | Mixer, Breathing Gases, Anesthesia Inhalation | 1 | 1 |
| CAW | Generator, Oxygen, Portable | 1 | 1 |
| FLL | Continuous Measurement Thermometer | 1 | 1 |
| KOI | Stimulator, Nerve, Peripheral, Electric | 1 | 1 |
Review panels
- Anesthesiology (12)
- General Hospital (5)
Most recent Fisher & Paykel Electronics , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K973161 | CPAP HUMIDIFIER (HC 200) | BZD | 1998-07-10 | 322 |
| K972885 | SERVO-CONTROL WALL-MOUNT COSYCOT INFANT WARMER MODEL IW960, MANUAL CONTROL WALL-MOUNT COSYCOT INFANT WARMER MODEL IW970 | FMT | 1997-10-30 | 86 |
| K971695 | SERVO-CONTROL COSYCOT INFANT WARMER, MANUAL-CONTROL COSYCOT INFANT WARMER | FMT | 1997-07-28 | 81 |
| K971461 | SERVO-CONTROL WALL-MOUNT INFANT WARMER(IW980)/MANUAL-CONTROL WALL-MOUNT INFANT WARMER(IW990) | FMT | 1997-07-16 | 86 |
| K970432 | INFANT RADIANT WARMER - MODELS IW910 AND IW920 | FMT | 1997-05-07 | 92 |
| K953392 | HC500 SERVO-CONTROLLED HEATED RESPIRATORY HUMIDIFIER (& ACCESSORIES) | BTT | 1996-03-12 | 237 |
| K953711 | AIR ENTRAINER 900RT008 | BZR | 1995-11-08 | 91 |
| K953949 | HUMIDIFIER & ACCESSORIES | CAW | 1995-10-16 | 55 |
| K934140 | MR290 HUMIDIFICATION CHAMBER SINGLE USE | BTT | 1994-01-24 | 152 |
| K924234 | CONS. CURRENT PERIPH. NERVE LOC. NS232,NS262,NS272 | KOI | 1993-05-27 | 276 |
7 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Fisher & Paykel Electronics , Ltd..
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.
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 Diagnostics (16 510(k)s)
- Fisher & Paykel Allied Products , Ltd. (12 510(k)s)
- Fisher & Paykel Healthcare Limited (8 510(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 Electronics , Ltd.?
FDA lists 17 510(k) clearances under the applicant name “Fisher & Paykel Electronics , Ltd.” (first 1988, latest 1998), across 9 product codes in 2 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 Electronics , Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Fisher & Paykel Electronics , Ltd. is 170 days.
Which FDA product codes appear under Fisher & Paykel Electronics , Ltd.?
The most frequent FDA product codes under this applicant name are BTT (Humidifier, Respiratory Gas, (Direct Patient Interface), 6); FMT (Warmer, Infant Radiant, 4); BTL (Ventilator, Emergency, Powered (Resuscitator), 1).
Next steps
- See all 17 Fisher & Paykel Electronics , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code BTT, Fisher & Paykel Electronics , 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, 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.