Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
HTF · Predicate Candidate Screening
3 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K890252 | BONE CURETTE | Kinetic Medical Products | 1989-01-27 | 9 | 0 |
| K870778 | ACROMED WALLIE-HEINIG CURETTES | Buckman Co., Inc. | 1987-03-09 | 11 | 0 |
| K841979 | 4MM CUP CURRETTE | Stainless Mfg., Inc. | 1984-06-19 | 36 | 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