Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Novatech SA — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
118 daysmedian FDA review time
269 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K242324 | DUTAU-NOVATECH® | Novatech SA | 2025-02-06 | 184 | 0 |
| K243126 | TRACHEOBRONXANE™ DUMON® | Novatech SA | 2024-10-29 | 29 | 0 |
| K170030 | NOVATECH TALCAIR | Novatech SA | 2017-03-13 | 68 | 0 |
| K151832 | NOVATECH TALCAIR | Novatech SA | 2016-03-31 | 269 | 0 |
| K971509 | ENDOXANE | Novatech SA | 1997-08-21 | 118 | 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