Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Etymotic Research — Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
82 daysmedian FDA review time
238 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K011114 | ETYMOTIC RESEARCH ER-10D OAE PROBE | Etymotic Research | 2001-07-03 | 82 | 0 |
| K010165 | ERO SCAN OAE TEST SYSTEM | Etymotic Research | 2001-03-12 | 53 | 0 |
| K980533 | ERO-SCAN OTOACOUSTIC EMISSIONS TEST INST. (ER34) | Etymotic Research | 1998-03-23 | 40 | 0 |
| K930553 | CUB DIS OTOACOUSTIC EMISSIONS TEST INSTRUMENT | Etymotic Research | 1993-09-29 | 238 | 0 |
| K930003 | TUBEPHONE MODELS ER-3A & ER-3 INSERT EARPHONES | Etymotic Research | 1993-06-18 | 165 | 0 |
| K873298 | ELEC-TIP | Etymotic Research | 1987-11-24 | 98 | 0 |
| K861113 | ER-7C CLINICAL PROBE MICROPHONE | Etymotic Research | 1986-04-23 | 29 | 0 |
| K843144 | K-BASS LO FREQUENCY HEARING AID | Etymotic Research | 1984-09-07 | 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