Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
HXW — 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) |
|---|---|---|---|---|---|
| K872949 | ACROMED BONE PLATE BENDER | Buckman Co., Inc. | 1987-10-15 | 79 | 0 |
| K870668 | DRIVER-BENDER-EXTRACTOR, BONE PIN | Military Engineering, Inc. | 1987-03-09 | 18 | 0 |
| K870084 | RD 140 SURGICAL BENDER | Terray Manufacturing, Inc. | 1987-01-28 | 20 | 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