Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Fisher & Paykel Allied Products , Ltd. · Predicate Candidate Screening

12 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

105 daysmedian FDA review time
150 days90th percentile
12clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K880702MODEL MR430 SPECIAL PURPOSE HUMID. HEATER BASESFisher & Paykel Allied Products , Ltd.1988-07-081370
K872138MR630 ENHANCED DUAL SERVO HEATER HUMIDIFIERFisher & Paykel Allied Products , Ltd.1987-10-071260
K872139MR420 TRANSPORT HUMIDIFIERFisher & Paykel Allied Products , Ltd.1987-09-151050
K863377MR338 SERVO HEATED DELIVERY HUMIDIFIERFisher & Paykel Allied Products , Ltd.1987-02-201700
K870055MR590 DUAL HOSE HEATER POWER PACKFisher & Paykel Allied Products , Ltd.1987-02-10340
K862923MR620 DUAL SERVO HEATED ANAESTHESIA HUMIDIFIERFisher & Paykel Allied Products , Ltd.1986-09-23530
K852962PERIPHERAL NERVE STIMULATOR MODEL A400Fisher & Paykel Allied Products , Ltd.1985-12-091500
K851879HEATED RESPIRATORY HUMIDIFIERFisher & Paykel Allied Products , Ltd.1985-09-031270
K850647HEATED RESPIRATORY HUMIFIFIER MR440Fisher & Paykel Allied Products , Ltd.1985-03-12210
K843903HEATED RESPIRATORY HUMIDIFIER MR428Fisher & Paykel Allied Products , Ltd.1984-10-22190
K832928SERVO HEATED RESPIRATORY HUMIDIFIERFisher & Paykel Allied Products , Ltd.1983-11-25930
K822816DUAL SERVO HEATED RESPIRATORY HUMIDIFIERFisher & Paykel Allied Products , Ltd.1982-10-22320

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda