Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
NFQ · 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) |
|---|---|---|---|---|---|
| K970116 | ESG-1 ELECTROSONOGRAM (ESG-1) | Myo-Tronics, Inc. | 1997-04-02 | 79 | 0 |
| K905657 | SONOPAK/QS, SONOPAK | Bioresearch | 1991-05-15 | 149 | 0 |
| K905449 | ELECTROSONOGRAM ESG-1 | Myo-Tronics, Inc. | 1991-04-26 | 142 | 0 |
| K862286 | ARTHROPHONOMETER | Arthrotek, Inc. | 1987-01-07 | 205 | 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