Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Therenva Sas — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
62 daysmedian FDA review time
103 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K222070 | EndoNaut | Therenva Sas | 2022-10-25 | 103 | 0 |
| K212383 | EndoNaut | Therenva Sas | 2021-08-31 | 29 | 0 |
| K171829 | EndoNaut | Therenva Sas | 2017-09-21 | 93 | 0 |
| K160376 | EndoSize | Therenva Sas | 2016-04-12 | 62 | 0 |
| K141475 | ENDOSIZE | Therenva Sas | 2014-07-31 | 57 | 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