Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
HXL · 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) |
|---|---|---|---|---|---|
| K882349 | MALLET, SURGICAL | Treace Medical, Inc. | 1988-06-23 | 16 | 0 |
| K872209 | ARTHROPLASTY MALLET | New England Surgical Instrument Corp. | 1987-06-23 | 14 | 0 |
| K871195 | MALLET, BONE SURGERY, STAINLESS STEEL, 2LB. | Military Engineering, Inc. | 1987-04-06 | 13 | 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