Omron BP6350 (HEM-6231T-Z)
Device Name:
BP6350
Device Model:
HEM-6231T-Z
Manufacturer:

Brand: Omron Corporation, Kyoto Head Office, Shiokoji Horikawa, Shimogyo ku, Kyoto 600-8530, JAPAN.

Distributer: OMRON Healthcare Inc., 1925 West Field Court, Lake Forest, Illinois 60045, UNITED STATES.

Other: Omron Healthcare Manufacturing Vietnam Co. Ltd., 28 VSIP II, Street 2, Vietnam-Singapore Industrial Park II, Hoa Phu Ward, Thu Dau Mot City, Binh Duong Province 820000, VIET NAM.

Measuring functions:
Blood Pressure and PR
Primary Client Use:
Intended for self-measurement and home use
Measurement Site:
Wrist
Measurement Occurrence:
Single measurements only
Availability:
Available Currently
Availability according to Countries or Regions:
United States
Device Manual:
Click here to download the Device Manual
Description:
The Omron BP6350 (HEM-6231T-Z) 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 wrist. It is intended for self-measurement and home use.
Assessment:
The technology used in the Omron BP6350 (HEM-6231T-Z), 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 AssessmentRecommendationBasis
BP Medaval None Although equivalence to another device is claimed, this has not been tested to MDR requirements.
BP AMA VDL (US) Self-measurement for adults Implied equivalence to the Omron HEM-6232T
Consumer BodyYear(s)LevelComment
BP Consumer Reports (US) 2021-2025 Very Good
Device Family:
Omron HEM-6232TL,P,Y, Omron RS7 Intelli IT (HEM-6232T-E)P, Omron BP6350 (HEM-6231T-Z)L, Omron HEM-6232T (HEM-6232T-AP)Y
Legend: L AHA VDL Implied Equivalence, P Stride Equivalence, Y Internal declaration
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 HEM-6232T

Saito K, Hishiki Y, Takahashi H. Validation of two automatic devices, Omron HEM-6232T and HEM-6181, for self-measurement of blood pressure at the wrist according to the ANSI/AAMI/ISO 81060-2:2013 protocol and the European Society of Hypertension International Protocol revision 2010. Vasc Health Risk Manag. 2019 Mar 6;15:47-55. doi: 10.2147/VHRM.S188089. PMID: 30881007. Available from: PMC6410757. eCollection 2019. Erratum in: Vasc Health Risk Manag. 2019 May 17;15:137.

81060-2:2013 - Pass General population

ESH-IP:2010 - Pass General population

The studies use the same data and are, therefore, not independent.

Omron RS7 Intelli IT (HEM-6232T-E)

Tasic D, Topouchian J, Dragisic D, Tasic N, Hakobyan Z, Vatinyan S, Zelveian P, Asmar R. Reproducibility of the European Society of Hypertension - International Protocol for validation of blood pressure measuring devices in obese patients. J Hypertens. 2019 Sep;37(9):1832-1837. doi: 10.1097/HJH.0000000000002106. PMID: 31246893.

ESH-IP:2010 - Pass Arm circumference at least 32 cm or obesity (Note: Validation by Serbian team)

ESH-IP:2010 - Pass Arm circumference at least 32 cm or obesity (Note: Validation by Armenian team)

Karampela I, Dalamaga M, Stratigou T, Antonakos G, Nikolopoulos M, Tzortzis E, Diomidous M. Validation of an Automatic Wrist Blood Pressure Monitor in a Critical Care Setting. Stud Health Technol Inform. 2020 Jun 26;272:171-174. doi: 10.3233/SHTI200521. PMID: 32604628.

IA protocol Critically ill patients (Note: IA validation (n=45/45 - one pair in each of the patients))

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