Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
HWJ · 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) |
|---|---|---|---|---|---|
| K895587 | CROSS MEDICAL PRODUCT PEDICLE AWL | Cross Medical Products, Inc. | 1990-01-04 | 111 | 0 |
| K880045 | ACROMED AWL/PUNCH, DEPTH GAUGE | Buckman Co., Inc. | 1988-02-17 | 42 | 0 |
| K875223 | DANNINGER ORTHOPAEDIC AWL | Danninger Medical Technology, Inc. | 1988-02-17 | 57 | 0 |
| K870779 | ACROMED WALLIE-HEINIG TROCHAR | Buckman Co., Inc. | 1987-03-09 | 11 | 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