Total clearances
3
2021-04-01 → 2026-09-10
Name variants in FDA filings: OMRON Healthcare, Inc. / Omron Healthcare, Inc.
Trend
Clearance cadence by quarter
Portfolio
Product codes worked
| Code |
Device name |
Class |
Specialty |
Clearances |
Most recent |
| DXN |
System, Measurement, Blood-Pressure, Non-Invasive |
Class II |
Cardiovascular |
2 |
2026-09-10 |
| QXY |
Oscillometric-Based, Over-The-Counter, Atrial Fibrillation Notification Feature |
Class II |
Cardiovascular |
1 |
2024-10-08 |
Filings
All 510(k) clearances (3)
| Date |
K-number |
Device |
Code |
Class |
Specialty |
| 2026-09-10 |
K261929 |
Upper Arm Blood pressure monitor (BP7155D) |
DXN |
Class II |
Cardiovascular |
| 2024-10-08 |
DEN230076 |
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)) |
QXY |
Class II |
Cardiovascular |
| 2021-04-01 |
K202228 |
Omron Model BP7900 Blood Pressure Monitor + EKG |
DXN |
Class II |
Cardiovascular |