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

Audina Hearing Instrument — Predicate Candidate Screening

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

58 daysmedian FDA review time
120 days90th percentile
8clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K964816AUDINA 153 BEHIND THE EAR AND AUDINA 158 BEHIND THE EARAudina Hearing Instrument1997-01-17490
K953960HEARING AID (ALL-IN-THE-EAR)Audina Hearing Instrument1995-09-12210
K942236AUDINA PREWIRES (FACEPLATE HEARING AID SERIES)Audina Hearing Instrument1994-06-17390
K936190BEHIND THE EAR HEARING AIDAudina Hearing Instrument1994-04-04980
K930271BEHIND-THE-EAR HEARING AIDAudina Hearing Instrument1993-03-18580
K897024MODEL AUDINA ITE HEATING AIDAudina Hearing Instrument1990-04-181200
K897023OVERSIGHT PROGRAM FOR IN-OFFICE ASSEMBLY, HRNG AIDAudina Hearing Instrument1990-03-16870
K820833AUDICRAFT VIP HEARING AIDAudina Hearing Instrument1982-04-09140

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