Atlas FDA

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

Omron Tateisi Electronics Co. — Predicate Candidate Screening

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

97 daysmedian FDA review time
184 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K881602OMRON DIGITAL BLOOD PRESSURE MONITOR MODEL HEM703COmron Tateisi Electronics Co.1988-06-15630
K881601OMRON DIGITAL BLOOD PRESSURE MONITOR MODEL HEM403COmron Tateisi Electronics Co.1988-06-15630
K871371DIGITAL SPHYGMOMANOMETEROmron Tateisi Electronics Co.1987-06-12660
K864466OMRON ULTRASONIC NEBULIZER MODEL NE-UO5Omron Tateisi Electronics Co.1987-03-261340
K854201OMRON DIGITAL BP MONITOR HEM-700CPOmron Tateisi Electronics Co.1986-04-171840
K853260OMRON DIGITAL BP MONITOR HEM-700COmron Tateisi Electronics Co.1985-11-181080
K851707OMRON DIGITAL BP MONITOR HEM-400COmron Tateisi Electronics Co.1985-07-31970

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