Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Etymotic Research, Inc. · 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) |
|---|---|---|---|---|---|
| K150491 | ER36 Series OAE Test System | Etymotic Research, Inc. | 2015-03-26 | 29 | 0 |
| K112733 | ER35 ERO-SCAN PRO HEARING TEST SYSTEM | Etymotic Research, Inc. | 2011-12-16 | 87 | 0 |
| K070880 | ER35 ERO-SCAN PRO HEARING TEST SYSTEM | Etymotic Research, Inc. | 2007-06-07 | 69 | 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