Atlas FDA

Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account

Robert Bosch Corp. — Predicate Candidate Screening

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

68 daysmedian FDA review time
216 days90th percentile
21clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K854491ERG 550 ERGOMETER BICYCLERobert Bosch Corp.1986-06-162160
K854492ERG 551 ERGOMETER, BICYCLERobert Bosch Corp.1986-06-162160
K854493ERG 555 COUCH ERGOMETERRobert Bosch Corp.1986-06-162160
K853541SP 4Robert Bosch Corp.1986-03-282140
K853154HV-4Robert Bosch Corp.1986-03-282420
K853271HEARING AID ANALYSIS SYSTEMRobert Bosch Corp.1986-01-161640
K851485DEFI 502Robert Bosch Corp.1985-08-291360
K840717ECS 502Robert Bosch Corp.1985-08-195490
K851937SONOMED 4Robert Bosch Corp.1985-07-17930
K850188BOSCH IN THE EAR HEARING AID SUPERSTARRobert Bosch Corp.1985-04-09810
K850186POST AURICULAR HEARING AIDS STAR 33PP, 44,55F &Robert Bosch Corp.1985-03-27680
K850190STAR 66F-AGC-I HEARING AIDRobert Bosch Corp.1985-03-25660
K850185BODY HEARING AIDS MT 80 SPRobert Bosch Corp.1985-03-25660
K850189BOSCH STAR 66PP-S HEARING AIDRobert Bosch Corp.1985-03-25660
K850187BOSCH STARR 66PP -HEARING AIDSRobert Bosch Corp.1985-03-25660
K842803INTERFERENZ 4Robert Bosch Corp.1984-08-21350
K842804DIADYN 4Robert Bosch Corp.1984-08-21350
K842801ULTRAMED 11S601Robert Bosch Corp.1984-08-01150
K842802VACOMED 4Robert Bosch Corp.1984-08-01150
K842805IMPULS 3, IT SELECTORRobert Bosch Corp.1984-08-01150
K790682TONOTEST BLOOD PRESSURE DEVICERobert Bosch Corp.1979-04-1100

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