Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
General Hearing Instruments, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
59 daysmedian FDA review time
77 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K061459 | TRANQUIL TRI-BTE | General Hearing Instruments, Inc. | 2006-06-30 | 35 | 0 |
| K974751 | TRANQUIL TRI-OE, TRANQUIL TRI-COE, TRANQUIL TRI-CIC | General Hearing Instruments, Inc. | 1998-03-06 | 77 | 0 |
| K971399 | AURIS AE, AURIS TL, AURIS HS, AURIS AC, AURIS MM, AURIS COE, | General Hearing Instruments, Inc. | 1997-06-13 | 59 | 0 |
| K943144 | AURIS CIC | General Hearing Instruments, Inc. | 1994-07-20 | 21 | 0 |
| K850123 | IN-TH-EAR HEARING AID | General Hearing Instruments, Inc. | 1985-03-21 | 66 | 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