Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
QAV · Predicate Candidate Screening
3 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K221338 | F&P Airvo 3 | Fisher & Paykel Healthcare | 2023-01-27 | 263 | 1 |
| K221318 | HVT 2.0 | Vapotherm, Inc. | 2022-12-13 | 221 | 0 |
| DEN170001 | Precision Flow® HVNI | Vapotherm, Inc. | 2018-04-10 | 462 | 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