Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Cousin Biotech Sas · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
259 daysmedian FDA review time
263 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K181086 | Cortical Fixation Systems | Cousin Biotech Sas | 2019-01-09 | 259 | 0 |
| K181799 | ResCUBE™ Ligament Fixation System | Cousin Biotech Sas | 2018-08-29 | 55 | 0 |
| K172206 | NAJA™ Ligament Correction System | Cousin Biotech Sas | 2018-04-10 | 263 | 0 |
| K133889 | PREMIUM | Cousin Biotech Sas | 2014-09-04 | 258 | 0 |
| K093196 | BIOMESH CA.B.S. 'AIR COMPOSITE, MODELS: CABST1R05T, CABSAIRC | Cousin Biotech Sas | 2010-06-25 | 259 | 0 |
| K072962 | CABS'AIR | Cousin Biotech Sas | 2008-06-26 | 251 | 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