Omron BP7450 (HEM-7342T-Z) 10 Series
Device Name:
BP7450 (10 Series)
Device Model:
HEM-7342T-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:
Upper Arm
Measurement Occurrence:
Single measurements only
Availability:
Available Currently
Availability according to Countries or Regions:
United States
Description:
The Omron BP7450 (HEM-7342T-Z) 10 Series is an automatic blood pressure monitor. Its blood pressure measurement technology has been proven to be accurate, with a 2-star Medaval rating. Blood pressure measurements are taken from the upper arm. It is intended for self-measurement and home use.
Assessment:
The technology used in the Omron BP7450 (HEM-7342T-Z) 10 Series, to measure blood pressure, has passed in a clinical validation study, in a general population, according to a recognised standard protocol, as published in a peer-reviewed publication.
Recommendations:
Accuracy AssessmentRecommendationBasis
BP Medaval ★★ Recommendation Recent clinical validation; recent protocol
BP Stride BP Self-measurement for adults (Unavailable) (Preferred) Published evidence
BP AMA VDL (US) Self-measurement for adults and pregnancy Published evidence
Consumer BodyYear(s)LevelComment
BP Consumer Reports (US) 2021-2025 Excellent, Recommended
Device Family:
Omron M7 Intelli IT (HEM-7320)L,F, Omron HEM-9210T (HEM-9210T-E)F, Omron BP742 (HEM-7200-Z)F, Omron BP7450 (HEM-7342T-Z) 10 SeriesL, Omron BP7900 (HEM-7530T-Z)F, Ranor RN-032AF, Ranor RN-032A-blackF, Ranor RN-032CF, Yuwell YE650A (V1)F, Yuwell YE670A (V1)F, Yuwell YE670DF, Yuwell YE660BF, Yuwell YE650D (V1)F
Legend: L AHA VDL Implied Equivalence, F FDA 510(k)
Validation Publications:

Peprah YA, Lee JY, Persell SD. Validation testing of five home blood pressure monitoring devices for the upper arm according to the ISO 81060-2:2018/AMD 1:2020 protocol. J Hum Hypertens. 2023 Feb;37(2):134-140. Epub: 2023 Jan 18. doi: 10.1038/s41371-022-00795-6. PMID: 36653402. Available from: PMC9957726.

81060-2:2018/Amd 1:2020 - Pass (n=85)

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-9210T (HEM-9210T-E)

Alpert BS. Validation of the Omron HEM-9210T by the ANSI/AAMI/ISO 81060-2:2013 with two novel cuffs: wide-range and extra-large. Blood Press Monit. 2017 Jun;22(3):166-8. Epub: 2017 Mar 1. doi: 10.1097/MBP.0000000000000250. PMID: 28252519.

81060-2:2013 - Pass General population

Van Den Heuvel JFM, Lely AT, Franx A, Bekker MN. Validation of the iHealth Track and Omron HEM-9210T automated blood pressure devices for use in pregnancy. Pregnancy Hypertens. 2019 Jan;15:37-41. Epub: 2018 Nov 2. doi: 10.1016/j.preghy.2018.10.008. PMID: 30825925.

ESH-IP:2010 - Pass Pregnancy (n=33), Pre-eclampsia (n=10)

Takahashi H. Validation of Home Blood Pressure-monitoring Devices Omron EVOLV (HEM-7600T-E), HEM-9210T, and M3 Comfort (HEM-7134-E) According to European Society of Hypertension International Protocol (ESH-IP) Revision 2010. J Clin Physiol (Jpn). 2019 Feb 1;49(1):37-46. doi: 10.34363/jocp.49.1_37. Available from: www.jstage.jst.go.jp.

ESH-IP:2010 - Pass General population

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