Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
GWX — 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) |
|---|---|---|---|---|---|
| K874966 | TUNING FORKS | Solway, Inc. | 1988-01-04 | 33 | 0 |
| K813304 | CONPHAR, TUNING FORKS | Conphar, Inc. | 1981-12-10 | 17 | 0 |
| K761132 | TUNING FORK | Fred Sammons, Inc. | 1976-12-02 | 13 | 0 |
| K760303 | FORK, TUNING BK-7519 | Fred Sammons, Inc. | 1976-09-08 | 47 | 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