Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Fine-Tune · 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) |
|---|---|---|---|---|---|
| K862095 | MODEL CA, HEARING AID | Fine-Tune | 1986-06-26 | 24 | 0 |
| K862036 | MODEL HP HEARING AID | Fine-Tune | 1986-06-23 | 25 | 0 |
| K861939 | MODEL PC HEARING AID | Fine-Tune | 1986-06-23 | 34 | 0 |
| K861254 | MODEL ST HEARING AID | Fine-Tune | 1986-04-23 | 20 | 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