Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Finetone Hearing Instruments — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
97 daysmedian FDA review time
174 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K974219 | FACEPLATE ASSEMBLY | Finetone Hearing Instruments | 1998-02-20 | 102 | 0 |
| K955692 | FINETONE FSC, | Finetone Hearing Instruments | 1996-02-02 | 50 | 0 |
| K945780 | FINETONE DISCEET CANAL | Finetone Hearing Instruments | 1994-12-21 | 26 | 0 |
| K940164 | SUPER-SIL | Finetone Hearing Instruments | 1994-06-29 | 174 | 0 |
| K830960 | CUSTOM IN-THE-EAR HEARING AID | Finetone Hearing Instruments | 1983-06-30 | 97 | 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