Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Fisher & Paykel Healthcare Limited · Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
210 daysmedian FDA review time
480 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K243583 | F&P Nova Nasal Mask | Fisher & Paykel Healthcare Limited | 2025-06-18 | 210 | 0 |
| K211560 | Airvo Nebulizer Adapter | Fisher & Paykel Healthcare Limited | 2021-12-10 | 204 | 0 |
| K191624 | F&P Nivairo RT047 Vented Hospital Full Face Mask, Anti-Asphy | Fisher & Paykel Healthcare Limited | 2020-03-09 | 265 | 0 |
| K173770 | OJR215 Pressure Relief Manifold | Fisher & Paykel Healthcare Limited | 2019-04-05 | 480 | 0 |
| K153505 | F&P Eson 2 Nasal Mask | Fisher & Paykel Healthcare Limited | 2016-09-20 | 288 | 0 |
| K130328 | F&P SIMPLUS FULL FACE MASK | Fisher & Paykel Healthcare Limited | 2013-06-05 | 114 | 0 |
| K121597 | ESON NASAL MASK | Fisher & Paykel Healthcare Limited | 2012-10-02 | 124 | 0 |
| K120027 | PILAIRO NASAL PILLOWS MASK | Fisher & Paykel Healthcare Limited | 2012-02-23 | 51 | 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