System, Measurement, Blood-pressure, Non-invasive
Omron Healthcare, Inc.'s record for this product code
MDR events29All time
Recalls0All time
510(k) clearances36All time
Recent MDR events
29 adverse event reports on file
- OMRON BLOOD PRESSURE MONITORMay 9, 2023InjuryMW5117434
- OMRON BLOOD PRESSURE MONITORJul 12, 2022MalfunctionMW5110823
- OMRON 3 SERIES UPPER ARM BLOOD PRESSURE MONITORApr 22, 2021Malfunction11705846
- OMRON 3 SERIES UPPER ARM BLOOD PRESSURE MONITORApr 22, 2021Malfunction11705870
- OMRON 3 SERIES UPPER ARM BLOOD PRESSURE MONITORApr 22, 2021Malfunction11705871
- OMRON 3 SERIES UPPER ARM BLOOD PRESSURE MONITORApr 22, 2021Malfunction11705872
- OMRON 3 SERIES UPPER ARM BLOOD PRESSURE MONITORApr 22, 2021Malfunction11705899
- OMRON 3 SERIES UPPER ARM BLOOD PRESSURE MONITORJan 12, 2021Malfunction11154034
- OMRON BLOOD PRESSURE MONITOR, BP786NSep 25, 2019MalfunctionMW5090040
- OMRON BP786NSep 18, 2018MalfunctionMW5079876
Recalls
0 recall events for this product code
No recalls on file for Omron Healthcare, Inc. under this product code.
510(k) clearances
36 clearances for this product code
- K202228Apr 1, 2021
Omron Model BP7900 Blood Pressure Monitor + EKG
- K190693Apr 17, 2019
HEM-6410T-ZL Wrist Blood Pressure Monitor
- K182579Mar 14, 2019
Omron Model BP7900 Blood Pressure Monitor + EKG
- K182481Nov 9, 2018
HEM-6410T-ZM Wrist Blood Pressure Monitor
- K182166Nov 8, 2018
Wrist Blood Pressure Monitor Model BP4350
- K182127Nov 2, 2018
Wrist Blood Pressure Monitor Model BP6100
- K163235Apr 20, 2017
HEM-9210T
- K163045Feb 21, 2017
Omron HEM-6400T-Z Wrist Blood Pressure Monitor
- K162092Nov 22, 2016
Evolv Model BP7000 Upper Arm Blood Pressure Monitor
- K142917Dec 1, 2014
BP652N (HEM-6300-Z)