Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
HWR · 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) |
|---|---|---|---|---|---|
| K915776 | KNEE PROSTHESIS DRIVER | Kim-Med, Inc. | 1992-06-11 | 170 | 0 |
| K875054 | ACROMED ADS BONE NAIL DRIVER | Buckman Co., Inc. | 1988-01-28 | 50 | 0 |
| K870847 | SCHULTZ PHALANGEAL COMPONENT DRIVER | Warsaw Orthopedic, Inc. | 1987-03-13 | 10 | 0 |
| K870848 | SCHULTZ METACARPAL COMPONENT DRIVER | Warsaw Orthopedic, Inc. | 1987-03-13 | 10 | 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