Omron HCR-1801
Device Name:
HCR-1801
Manufacturer:
Omron Corporation, Kyoto Head Office, Shiokoji Horikawa, Shimogyo ku, Kyoto 600-8530, JAPAN.
Measuring functions:
Blood pressure
Primary Client Use:
Intended for use as a public facility
Measurement Site:
Upper Arm
Measurement Occurrence:
Single measurements only
Availability:
Available Currently
Description:
The Omron HCR-1801 is an automatic blood pressure monitor. The accuracy of its blood pressure measurement technology has yet to be proven to MDR requirements. Blood pressure measurements are taken from the upper arm. It is intended for use as a public facility.
Assessment:
The technology used in the Omron HCR-1801, to measure blood pressure, has been compared to a clinically validated device, but the results of the equivalence study have not been published and cannot be verified; nor can the protocol be checked for compliance with (EU) 2017/745 and MEDDEV 2.7/1 rev 4.
Recommendations:
| Accuracy Assessment | Recommendation | Basis | |
| BP | Medaval | None | Although equivalence to another device is claimed, this has not been tested to MDR requirements. |
| BP | Japanese Society of Hypertension | Self-measurement (2024) | Manufacturer declaration of equivalence to the Omron HEM-1026 |
Device Family:
Validation Publications for Equivalent Devices:
Note: This is a provisional list, as equivalence according to EU Regulation 2017/745 (e.g. MEDDEV 2.7/1 rev 4) is not proven. Accordingly, these publications are not used in the assessment of star-ratings.
Omron HCR-1901T2/HCR-1902T2 (HEM-1026)
Takahashi H, Yamashita S, Yakura N. Validating the Accuracy of Omron HEM-1026 (HCR-1901T2/HCR-1902T2): Blood Pressure Monitoring Device at Home, According to the Universal Protocol. Vasc Health Risk Manag. 2024 Jul 22;20:333-339. doi: 10.2147/VHRM.S468382. PMID: 39070216. Available from: PMC11277893.
81060-2:2020 - Pass General population