Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in JapanLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Omron Corporation and its 3 subsidiaries with 100 510(k) clearances. The most recent is a 510(k) clearance dated Sep 10, 2026: Upper Arm Blood pressure monitor (BP7155D).
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date, Omron Corporation and its 3 subsidiaries
A hatched bar is a year that is not over, so its count covers only part of the year.
| Sep 10, 2026 | Upper Arm Blood pressure monitor (BP7155D)K261929 · DXN | 510(k) clearances |
| Oct 8, 2024 | Omron Blood Pressure Monitor with Atrial Fibrillation (AFib) Detection Feature (BP7460 (HEM-7371T1-AZ)); Omron Blood Pressure Monitor with Atrial Fibrillation (AFib) Detection Feature (BP5460 (HEM-7372T1-AZAZ))DEN230076 · QXY | 510(k) clearances |
| Apr 1, 2021 | Omron Model BP7900 Blood Pressure Monitor + EKGK202228 · DXN | 510(k) clearances |
| Sep 7, 2019 | Focus TENS Therapy, Model PM710-M/-LK183215 · NUH | 510(k) clearances |
| Apr 17, 2019 | HEM-6410T-ZL Wrist Blood Pressure MonitorK190693 · DXN | 510(k) clearances |
| Mar 14, 2019 | Omron Model BP7900 Blood Pressure Monitor + EKGK182579 · DXN | 510(k) clearances |
| Jan 10, 2019 | Maxpower ReliefK182120 · NUH | 510(k) clearances |
| Nov 9, 2018 | Heat Pain ProK181992 · NUH | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
