Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Sonotone Intl., Inc. — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K914897 | SONOTONE BEHIND THE EAR MODEL ST 54-0 | Sonotone Intl., Inc. | 1992-01-10 | 71 | 0 |
| K915519 | SONOTONE BEHIND THE EAR MODEL ST 53A | Sonotone Intl., Inc. | 1992-01-09 | 59 | 0 |
| K915517 | SONOTONE BODY AID MODEL ST 1000 BODY WORN | Sonotone Intl., Inc. | 1992-01-09 | 59 | 0 |
| K915518 | SONOTONE BEHIND THE EAR MODEL ST 49 | Sonotone Intl., Inc. | 1992-01-09 | 59 | 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