Fisher & Paykel Allied Products , Ltd.: FDA clearances and approvals
Fisher & Paykel Allied Products , Ltd. has 12 FDA 510(k) clearances (first 1982, latest 1988), across 2 product codes in 1 review panel. Median 510(k) review time: 99 days.
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) | 11 | 11 |
| BXN | Stimulator, Nerve, Battery-Powered | 1 | 1 |
Review panels
- Anesthesiology (12)
Most recent Fisher & Paykel Allied Products , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K880702 | MODEL MR430 SPECIAL PURPOSE HUMID. HEATER BASES | BTT | 1988-07-08 | 137 |
| K872138 | MR630 ENHANCED DUAL SERVO HEATER HUMIDIFIER | BTT | 1987-10-07 | 126 |
| K872139 | MR420 TRANSPORT HUMIDIFIER | BTT | 1987-09-15 | 105 |
| K863377 | MR338 SERVO HEATED DELIVERY HUMIDIFIER | BTT | 1987-02-20 | 170 |
| K870055 | MR590 DUAL HOSE HEATER POWER PACK | BTT | 1987-02-10 | 34 |
| K862923 | MR620 DUAL SERVO HEATED ANAESTHESIA HUMIDIFIER | BTT | 1986-09-23 | 53 |
| K852962 | PERIPHERAL NERVE STIMULATOR MODEL A400 | BXN | 1985-12-09 | 150 |
| K851879 | HEATED RESPIRATORY HUMIDIFIER | BTT | 1985-09-03 | 127 |
| K850647 | HEATED RESPIRATORY HUMIFIFIER MR440 | BTT | 1985-03-12 | 21 |
| K843903 | HEATED RESPIRATORY HUMIDIFIER MR428 | BTT | 1984-10-22 | 19 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Fisher & Paykel Allied Products , Ltd..
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 Allied Products , Ltd. have?
Fisher & Paykel Allied Products , Ltd. has 12 FDA 510(k) clearances (first 1982, latest 1988), across 2 product codes in 1 review panel.
How long does FDA take to clear Fisher & Paykel Allied Products , Ltd.'s 510(k)s?
The median time from FDA receipt to decision across Fisher & Paykel Allied Products , Ltd.'s cleared 510(k)s is 99 days.
What devices does Fisher & Paykel Allied Products , Ltd. make?
Its most frequent FDA product codes are BTT (Humidifier, Respiratory Gas, (Direct Patient Interface), 11); BXN (Stimulator, Nerve, Battery-Powered, 1).
Has Fisher & Paykel Allied Products , Ltd. had device recalls?
openFDA lists no recalls under a recalling firm name matching Fisher & Paykel Allied Products , Ltd. Related entities may recall under other names.
Next steps
- See all 12 Fisher & Paykel Allied Products , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code BTT, Fisher & Paykel Allied Products , 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.