Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Rovers Diagnostic Devices — Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K941472 | CERVEX-BRUSH PAP KIT | Rovers Diagnostic Devices | 1995-02-28 | 337 | 0 |
| K942843 | CERVEX-BRUSH(R), STERILE, SPATULA, CERVICAL, CYTOLOGY | Rovers Diagnostic Devices | 1994-12-08 | 175 | 0 |
| K942144 | URETHRA-BRUSH | Rovers Diagnostic Devices | 1994-06-27 | 55 | 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