Atlas FDA

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

Audiotone, Inc. — Predicate Candidate Screening

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

30 daysmedian FDA review time
73 days90th percentile
12clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K881737AUDIOTONE MODEL AVATAR IN-THE-EAR HEARING AIDAudiotone, Inc.1988-05-13210
K881738AUDIOTONE MODEL TLC SECRET IN-THE-EAR HEARING AIDAudiotone, Inc.1988-05-13210
K881653AUDIOTONE MODEL ASP SECRET IN-THE-EAR HEARING AIDAudiotone, Inc.1988-05-13280
K881652AUDIOTONE MODEL A-61 BEHIND-THE-EAR HEARING AIDAudiotone, Inc.1988-05-11260
K880223MAGIC EAR MODEL MB BEHIND-THE-EAR HEARING AIDAudiotone, Inc.1988-03-14540
K880225MAGIC EAR MODEL CI IN-THE-EAR HEARING AIDAudiotone, Inc.1988-03-09490
K880224MAGIC EAR MODEL MC BEHIND-THE-EAR HEARING AIDAudiotone, Inc.1988-03-07470
K874384AUDIOTONE MODEL A-90, BEHIND-THE-EAR HEARING AIDAudiotone, Inc.1988-01-19850
K874385AUDIOTONE MODEL MSP, IN-THE-EAR HEARING AIDAudiotone, Inc.1988-01-07730
K874323MODEL A-70, BEHIND-THE-EAR HEARING AIDAudiotone, Inc.1987-11-20300
K874324MODEL A-17, BEHIND-THE-EAR HEARING AIDAudiotone, Inc.1987-11-16260
K874325MODEL A-72, BEHIND-THE-EAR HEARING AIDAudiotone, Inc.1987-11-12220

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