Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
GFJ — 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) |
|---|---|---|---|---|---|
| K851789 | 29-200 TO 29-230 VARIOUS BONE MALLETS(WIHIGER, DOY | Artiberia | 1985-06-20 | 56 | 0 |
| K844017 | MICROTENS 7757 T.E.N.S. STIMULATOR | Rabar, Inc. | 1984-11-30 | 46 | 0 |
| K822204 | ENT MALLETS | Kelleher Corp. | 1982-09-17 | 56 | 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