Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Omni Hearing Systems — Predicate Candidate Screening

7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

40 daysmedian FDA review time
73 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K843921IN THE CANAL HEARING AID RC, REDICANALOmni Hearing Systems1984-11-01270
K833333IN THE EAR HEARING AID OMNI 100Omni Hearing Systems1983-12-08720
K833334BEHIND THE EAR ASP-BBOmni Hearing Systems1983-11-14480
K833451TEL-STAR NUWAY & GENERIC E ASP-BPOmni Hearing Systems1983-11-14400
K830459BEHIND THE EAR HEARING AID OMNI #OSOmni Hearing Systems1983-03-07200
K823178TEL-STAR NU-WAY & GENERIC EOmni Hearing Systems1983-01-07730
K811158OMNIOmni Hearing Systems1981-05-27290

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