Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
MNL · Predicate Candidate Screening
4 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K950689 | UCB | Cox Medical Ent., Inc. | 1995-03-06 | 20 | 0 |
| K946293 | MILL-ROSE SCOPE CLEANING BRUSH | Mill-Rose Laboratory | 1995-02-16 | 51 | 0 |
| K892218 | ENDO-SPONGE | Endovations | 1989-05-31 | 58 | 0 |
| K874239 | CLEANING BRUSH | Endovations | 1987-12-29 | 74 | 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