FDA applicant
Fisher & Paykel Healthcare, Ltd.
FDA records 83 decisions for Fisher & Paykel Healthcare, Ltd. (Auckland, NZ) from 1988 to 2025: 83 510(k) clearances. Most are in product codes BZD (Ventilator, Non-Continuous (Respirator)) and BTT (Humidifier, Respiratory Gas, (Direct Patient…). Since 2016 its 510(k)s took a median of 230 days from receipt to decision, against 221 for FDA’s reviews in the same codes and years. Its devices cite 113 predicates, 83 of them its own earlier devices. 16 recalls are linked to its devices.
FDA’s records also spell it “Fisher & Paykel Healthcare Limited”, “Fisher & Paykel Healthcare”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Fisher & Paykel Healthcare, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
6in 2025
2026 so far, outlined.
Recalls per year
1in 2025
Class I Class II/III not classified
Planning a device like Fisher & Paykel Healthcare, Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportOther applicant names beginning “Fisher”
FDA records each applicant name separately; these may or may not be the same firm.