Atlas FDA

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

Bosch Hearing Instruments, Inc. — Predicate Candidate Screening

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

57 daysmedian FDA review time
691 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K840571EKG 503ABosch Hearing Instruments, Inc.1985-12-306910
K840569EKG 501 ABosch Hearing Instruments, Inc.1985-12-306910
K840574EBM-500Bosch Hearing Instruments, Inc.1985-11-146450
K822579BOSCH STAR 66F-SP HEARING AIDBosch Hearing Instruments, Inc.1982-09-30360
K820041BOSCH TOP STAR IIIBosch Hearing Instruments, Inc.1982-01-22150
K810347BOSCH STAR 66F SUPER EARLEVEL AIDBosch Hearing Instruments, Inc.1981-03-31490
K800779OMNITON MT80-A BODY HEARING AIDBosch Hearing Instruments, Inc.1980-06-04570

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