Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
GN Hearing A/S — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
90 daysmedian FDA review time
277 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K254108 | Jabra Enhance Select Self-fit (Jabra Enhance Select 550) | GN Hearing A/S | 2026-06-25 | 188 | 0 |
| K213424 | Jabra Enhance Plus | GN Hearing A/S | 2022-01-19 | 90 | 0 |
| K193303 | Tinnitus Sound Generator Module | GN Hearing A/S | 2020-02-20 | 83 | 0 |
| K180495 | Tinnitus Sound Generator Module | GN Hearing A/S | 2018-11-30 | 277 | 0 |
| K181586 | Tinnitus Sound Generator Module | GN Hearing A/S | 2018-07-13 | 28 | 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