Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Fisher and Paykel Healthcare Limited · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K233829 | Nova Micro Pillows Mask Small A Model (NVP1SA); Nova Micro P | Fisher and Paykel Healthcare Limited | 2024-08-23 | 266 | 0 |
| K173060 | F&P NivairoTM RT046 Non-Vented Hospital Full Face Mask, Stan | Fisher and Paykel Healthcare Limited | 2018-01-25 | 119 | 0 |
| K170367 | Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyx | Fisher and Paykel Healthcare Limited | 2017-08-24 | 199 | 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