Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
HWA — 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) |
|---|---|---|---|---|---|
| K933527 | MODIFICATION OF ANTERIOR SEGMENT ELECTRODES | Mira, Inc. | 1994-01-25 | 189 | 0 |
| K864422 | RAYLOR(TM) MALLET | Cedar Surgical, Inc. | 1986-11-24 | 14 | 0 |
| K841627 | MALLET | Plastafil, Inc. | 1984-08-27 | 130 | 0 |
| K770205 | CEMENT CHISELS | Depuy, Inc. | 1977-02-08 | 8 | 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