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

Omron Electronics, Inc. — Predicate Candidate Screening

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

81 daysmedian FDA review time
228 days90th percentile
10clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K902255OMRON PULSE STIMULATOR MODEL HV-F05Omron Electronics, Inc.1990-10-311630
K894563OMRON DIGITAL BLOOD PRESSURE MONITOR MODEL HEM814FOmron Electronics, Inc.1990-03-062280
K893029OMRON TRAVEL MASSAGER, MODEL HM-01Omron Electronics, Inc.1989-05-31370
K881415OMRON DIGITAL FEVER THERMOMETER MODEL MC-3Omron Electronics, Inc.1988-10-041830
K882393DIGITAL BLOOD PRESSURE MONITOR MODEL HEM-703CPOmron Electronics, Inc.1988-08-30810
K881269OMRON DIGITAL BLOOD PRESSURE MONITOR HEM-701COmron Electronics, Inc.1988-06-16840
K872527OMRON DIGITAL FEVER THERMOMETER MODEL MC-12BOmron Electronics, Inc.1987-07-23280
K871888DIGITAL FEVER THERMOMETER MODEL MC-5Omron Electronics, Inc.1987-06-17340
K871207OMRON DIGITAL BLOOD PRESSURE MONITOR HEM-401COmron Electronics, Inc.1987-05-28640
K870956OMRON DIGITAL FEVER THERMOMETER MODEL MC-7Omron Electronics, Inc.1987-04-16370

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