Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Cooper Surgical · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
66 daysmedian FDA review time
73 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253698 | Milex™ Incontinence Dish Pessaries; Milex™ Incontinence Dish | Cooper Surgical | 2026-01-20 | 57 | 0 |
| K091325 | TEN-YEAR FRACTURE RISK OPTION AND SIRI TABLE OPTION FOR NORL | Cooper Surgical | 2009-06-29 | 55 | 0 |
| K023382 | COOPERSURGICAL MALLEABLE SYTLET | Cooper Surgical | 2002-12-20 | 73 | 0 |
| K023384 | COOPERSURGICAL TRIAL TRANSFER CATHETER | Cooper Surgical | 2002-12-13 | 66 | 0 |
| K023383 | COOPERSURGICAL INTRAUTERINE INSEMINATION CATHETER | Cooper Surgical | 2002-12-13 | 66 | 0 |
| K023379 | COOPERSURGICAL EMBRYO TRANSFER CATHETER, COOPERSURGICAL ASSI | Cooper Surgical | 2002-12-11 | 64 | 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