Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Fisher & Paykel Healthcare · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
463 daysmedian FDA review time
828 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K222292 | F&P myAirvo 3 | Fisher & Paykel Healthcare | 2024-05-08 | 649 | 0 |
| K220703 | F&P 950 Respiratory Humidifier | Fisher & Paykel Healthcare | 2023-06-16 | 463 | 0 |
| K221338 | F&P Airvo 3 | Fisher & Paykel Healthcare | 2023-01-27 | 263 | 1 |
| K162553 | AirSpiral Heated Breathing Tube | Fisher & Paykel Healthcare | 2018-12-20 | 828 | 0 |
| K162582 | HumiGard Surgical Humidification System, HumiGard Humdified | Fisher & Paykel Healthcare | 2017-06-23 | 281 | 0 |
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