Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
BWA — 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) |
|---|---|---|---|---|---|
| K963305 | ALEXANDER BOX, BATTERY, RECHARGEABLE | Alexander Mfg. Co. | 1997-04-17 | 238 | 0 |
| K874794 | E600B FOOTSWITCH | Valleylab, Inc. | 1987-12-14 | 21 | 0 |
| K873809 | EXCALIBUR ELECTROSURGICAL UNIT 60-5200-001 | Zimmer Aspen Labs | 1987-11-20 | 63 | 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