Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Earlens Corporation · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K182480 | Earlens Contact Hearing Aid | Earlens Corporation | 2019-01-25 | 137 | 0 |
| K153634 | Wireless Earlens Light Driven Hearing Aid | Earlens Corporation | 2016-04-06 | 110 | 0 |
| DEN150002 | EarLens Contact Hearing Device | Earlens Corporation | 2015-09-29 | 270 | 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