FDA applicant
Fisher & Paykel Electronics, Ltd.
FDA records 17 decisions for Fisher & Paykel Electronics, Ltd. (Auckland, New Zealand, NZ) from 1988 to 1998: 17 510(k) clearances. Most are in product codes BTT (Humidifier, Respiratory Gas, (Direct Patient…) and FMT (Warmer, Infant Radiant). Its devices cite 10 predicates, 5 of them its own earlier devices. 2 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Fisher & Paykel Electronics, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Fisher & Paykel Electronics, Ltd. since 2007.
Recalls per year
1in 2014
Class I Class II/III not classified
Planning a device like Fisher & Paykel Electronics, 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.