Accuracy Assessment | Recommendation | Basis | |
BP | Medaval | ★★ Recommendation | Recent clinical validation; recent protocol |
BP | BIHS (UK and IRL) | Self-measurement | Published evidence |
BP | Hypertension Canada | Self-measurement (Previous) (Gold) | Manufacturer declaration of equivalence |
BP | Stride BP | Self-measurement for adults (Preferred) | Published evidence |
BP | AMA VDL (US) | Self-measurement | Published evidence |
BP | MDR Criteria | Self-measurement | Published evidence |
Consumer Body | Year(s) | Level | Comment | |
BP | Choice (Australia) |
Legend: P Stride Equivalence, F FDA 510(k)
Kollias A, Anagnostopoulos I, Gravvani A, Stambolliu E, Bountzona I, Menti A, Stergiou GS. Validation of the InBody BP170 oscillometric home blood pressure monitor in general population according to the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization Universal Standard. Blood Press Monit. 2020 Feb;25(1):50-52. Epub: 2019 Oct 15. doi: 10.1097/MBP.0000000000000410. PMID: 31633518.
81060-2:2019 - Pass General population
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.
KOROT P3 Accurate (InBody BPBIO480KV)
Ntineri A, Theodosiadi A, Menti A, Kyriakoulis KG, Ntousopoulos V, Kollias A, Stergiou GS. A novel professional automated auscultatory blood pressure monitor with visual display of Korotkoff sounds: InBody BPBIO480KV validation according to the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization Universal Standard. J Hypertens. 2023 Feb 1;41(2):356-361. Epub: 2022 Dec 14. doi: 10.1097/HJH.0000000000003341.. PMID: 36524556.
81060-2:2019 - Pass General population
Fania C, Giletto A, Niero A, Palatini P. Accuracy of the KOROT P3 Accurate automated auscultatory blood pressure measuring device for professional use in people with extra-large arms. Blood Press Monit. 2024 Jun 1;29(3):144-148. Epub: 2024 Feb 23. doi: 10.1097/MBP.0000000000000696. PMID: 38390635.
81060-2:2019 - Pass Extra-Large arms
EN ISO 81060-2 special patient population (37 participants).