Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Gn Danavox, Inc. — Predicate Candidate Screening
10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
88 daysmedian FDA review time
241 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K971032 | DANAVOX MODELS 163/162 BTE | Gn Danavox, Inc. | 1997-06-17 | 88 | 0 |
| K971031 | AUDALLION III HEARING SYSTEM | Gn Danavox, Inc. | 1997-06-17 | 88 | 0 |
| K942331 | DANAVOX MODEL CIC | Gn Danavox, Inc. | 1994-11-15 | 183 | 0 |
| K924185 | DFS GENIUS BTE | Gn Danavox, Inc. | 1992-11-03 | 75 | 0 |
| K905692 | 143 SERIES BTE | Gn Danavox, Inc. | 1991-01-28 | 40 | 0 |
| K905679 | 133 SERIES BTE | Gn Danavox, Inc. | 1991-01-28 | 40 | 0 |
| K896996 | CAS (COMPUTERIZED ANALYZER SYSTEM) | Gn Danavox, Inc. | 1990-08-09 | 241 | 0 |
| K896995 | DISCRETION, IN THE CANAL HEARING INSTRUMENT | Gn Danavox, Inc. | 1990-04-30 | 140 | 0 |
| K891594 | CERUMEN FILTER | Gn Danavox, Inc. | 1989-05-10 | 51 | 0 |
| K863975 | CUSTOM IN-THE-EAR | Gn Danavox, Inc. | 1986-11-07 | 24 | 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