Omron HEM-9210T (HEM-9210T-E)
Device Name:
HEM-9210T
Device Model:
HEM-9210T-E
Manufacturer:
Omron Corporation, Kyoto Head Office, Shiokoji Horikawa, Shimogyo ku, Kyoto 600-8530, JAPAN.
Measuring functions:
Blood pressure
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 HEM-9210T (HEM-9210T-E) 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 HEM-9210T (HEM-9210T-E), to measure blood pressure, has passed in three clinical validation studies, between general and pregnancy populations, according to recognised standard protocols, as published in peer-reviewed publications.
Recommendations:
Accuracy AssessmentRecommendationBasis
BP Medaval ★★ Recommendation Recent clinical validation; older protocol; multiple clinical validations
BP BIHS (UK and IRL) NOT recommended; previous publication now retracted. (Previous) Published evidence
BP ESH (Europe) Self-measurement Published evidence
BP Stride BP Self-measurement for adults and pregnancy (Unavailable) (Preferred) Published evidence
BP AMA VDL (US) Self-measurement Published evidence plus 510(k) K163235
BP FDA (US) 510(k) 510(k) K163235
BP MDR Criteria Self-measurement Published evidence
Device Family:
Omron M7 Intelli IT (HEM-7320)F, Omron HEM-9210T (HEM-9210T-E)F, Omron BP742 (HEM-7200-Z)F, 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: F FDA 510(k)
Validation Publications:

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

Relevant Publications:

Padwal RS. 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 Dec;22(6):379. doi: 10.1097/MBP.0000000000000295. PMID: 29112058.

The publication is a letter or correspondence in which the Omron HEM-9210T is referenced.

Alpert BS. Response to Regarding: validation of the Omron HEM-9210T by the ANSI/AAMI/ISO 81060-2 with two novel cuffs wide-range and extra-large Blood Press Monit. 2017 Dec;22(6):379-80. doi: 10.1097/MBP.0000000000000291. PMID: 29112059.

The publication is a letter or correspondence in which the Omron HEM-9210T is referenced.

Takahashi H. 欧州高血圧学会国際プロトコル(ESH-IP)改訂2010年版による家庭血圧監視装置Omron EVOLV(HEM-7600T-E),HEM-9210T,およびM3Comfort(HEM-7143-E)の妥当性確認. [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.] 日本臨床生理学会雑誌 [J Clin Physiol (Jpn)]. 2018 Feb 1;48(1):29-38. Retraction in: J Clin Physiol (Jpn). 2019 Feb 1;49(1):37-46.

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