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

Danavox, Inc. — Predicate Candidate Screening

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

19 daysmedian FDA review time
79 days90th percentile
26clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K940608155 PP AGC-IDanavox, Inc.1994-05-04790
K851069BODY TYPE HEARING AID 107SDanavox, Inc.1985-06-05790
K843791BEHIND-THE-EAR 123 VTHDanavox, Inc.1984-11-09430
K833486IN-THE-EAR HEARING AID MODELDanavox, Inc.1984-06-222590
K832326BEHIND-THE-EAR #123 AGCIDanavox, Inc.1983-09-29760
K832751BEHIND-THE-EAR SERIES 125Danavox, Inc.1983-09-29450
K823073101M IN-THE-EARDanavox, Inc.1983-01-07800
K823531BEHIND-THE-EAR HEARING AID #8003Danavox, Inc.1982-12-15160
K822655BEHIND-THE-EAR MODEL 115 V AGC O WDanavox, Inc.1982-09-14120
K822619BEHIND-THE-EAR MODEL 115PPPCWDanavox, Inc.1982-09-14120
K822387BEHIND-THE-EAR MODEL SERIES 123Danavox, Inc.1982-08-19100
K812937BEHIND-THE-EAR MODEL 115Danavox, Inc.1981-11-06170
K812939IN-THE-EAR MODEL 101MDanavox, Inc.1981-11-06170
K812938IN-THE-EAR MODEL 821Danavox, Inc.1981-11-06170
K802859BEHIND-THE-EAR HEARING AIDDanavox, Inc.1980-12-31490
K800345MODEL 795U BEHIND THE EAR HEARING AIDDanavox, Inc.1980-03-12220
K792334BEHINDTHEEAR HEAR. AID MOD. 793U,M,UH,MHDanavox, Inc.1979-12-18290
K790539HEARING AID DANAVOX 775VDanavox, Inc.1979-04-10210
K790515BEHIND-THE-EAR HEARING AIDDanavox, Inc.1979-04-03190
K781881HEARING AID, MODEL 781Danavox, Inc.1978-11-1590
K781595BODY-WORN HEARING AID, MODEL 787PPDanavox, Inc.1978-09-27120
K781596HEARING AID, MODEL 775 PP/AGCDanavox, Inc.1978-09-27120
K781212HEARING AID, MODEL 783DUDanavox, Inc.1978-08-14280
K780546BEHIND-THE-EAR MASKING AMPLIFIER,735SDanavox, Inc.1978-04-1050
K771607HEARING AID MODEL 775Danavox, Inc.1977-08-2530
K770321PERCEPTORDanavox, Inc.1977-02-28110

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