Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
QNW · Predicate Candidate Screening
2 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K231473 | Monarch Bronchoscope | Auris Health, Inc., A Johnson and Johnson Family Company | 2023-11-28 | 190 | 1 |
| K203614 | Monarch Bronchoscope | Auris Health, Inc., A Johnson and Johnson Family Company | 2021-03-11 | 91 | 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