Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Gn Otometrics A/S — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
95 daysmedian FDA review time
303 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K143670 | ICS CHARTR EP 200 WITH VEMP | Gn Otometrics A/S | 2015-10-23 | 303 | 0 |
| K110286 | GN OTOMETRICS TYPE 1053 FREEFIT | Gn Otometrics A/S | 2011-04-28 | 87 | 0 |
| K083399 | ICS CHARTR EP 200 | Gn Otometrics A/S | 2009-02-20 | 95 | 0 |
| K061791 | FOCUS VNG/ENG TYPE 1068 | Gn Otometrics A/S | 2006-07-11 | 15 | 0 |
| K061104 | SPEECHLINK 100 TYPE 1053 | Gn Otometrics A/S | 2006-05-03 | 13 | 0 |
| K033645 | OTOFLEX 100 TYE 1012 | Gn Otometrics A/S | 2004-03-31 | 132 | 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