Atlas FDA

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

Bernafon, Inc. — Predicate Candidate Screening

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

42 daysmedian FDA review time
65 days90th percentile
16clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K880349MODEL 759 CUSTOM IN-THE-EAR HEARING AIDBernafon, Inc.1988-03-07410
K874589BERNAFON COLIBRI, C-2H HEARING AIDSBernafon, Inc.1987-12-04250
K864823BEHIND THE EAR HEARING AIDS, BERNAFON COLIBRI, C1Bernafon, Inc.1987-01-06280
K864180INTEGRA, CUSTOM IN-THE-EAR HEARING AIDBernafon, Inc.1986-11-0590
K860759CHARISMA HEARING AIDBernafon, Inc.1986-04-11420
K855240BEHIND THE EAR HEARING AIDS MODELBernafon, Inc.1986-03-12710
K851547BEHIND THE EAR HEARING AID MODEL BERNAFON T-82Bernafon, Inc.1985-05-29430
K844985IN THE EAR MODEL X-ITE 84Bernafon, Inc.1985-01-23280
K844621BEHIND THE EAR HEARING AID BERNAFON T-88PBernafon, Inc.1985-01-07410
K844425BEHIND THE EAR HEARING AIDS BERNAFON X-13Bernafon, Inc.1985-01-04500
K842546CUSTOM CANAL HEARING AID X-CITE 84Bernafon, Inc.1984-09-05650
K842434BEHING THE EAR HEARING AID T-98Bernafon, Inc.1984-08-23640
K840480BEHIND THE EAR HEARING AID T-97Bernafon, Inc.1984-03-30560
K840479BEHING-THE-EAR HEARING AID T-85DBernafon, Inc.1984-03-30560
K833775BEHIND-THE-EAR HEARING AIDS T-87 &Bernafon, Inc.1983-12-08420
K831217MODEL BERNAFON T-86Bernafon, Inc.1983-05-09240

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