![](/images/devices/Andon/KD-558.jpg)
Accuracy Assessment | Recommendation | Basis | |
BP | Medaval | None | Although equivalence to another device is claimed, this has not been tested to MDR requirements. |
BP | BIHS (UK and IRL) | Self-measurement | Manufacturer declaration of equivalence |
BP | ESH (Europe) | Self-measurement | The BIHS recommendation, despite the absence of the scientific evidence required by the same authors' criteria. |
Legend: B BIHS Derivative, D DET Equivalence, P Stride Equivalence, Y Internal declaration, Z Almost Certain
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.
Andon KD-5031
Wu N, Zhang X, Wang W, Zhang H. Validation of the Andon KD5031 for clinical use and self-measurement according to the European Society of Hypertension International Protocol. Blood Press Monit. 2016 Oct;21(5):310-2. Epub: 2016 Jul 7. doi: 10.1097/MBP.0000000000000204. PMID: 27392206.
ESH-IP:2010 - Pass General population
Andon KD-5915
Huang QF, Wang J, Sheng CS, Zhang NN, Li Y, Wang JG. Validation of the ANDON KD-5915 blood pressure monitor for home blood pressure monitoring according to the European Society of Hypertension International Protocol. Blood Press Monit. 2010 Aug;15(4):232-4. PMID: 20658765.
ESH-IP:2002 - Pass General population
Andon KD-5917
Guo WG, Li BL, He Y, Xue YS, Wang HY, Zheng QS, Xiang DC. Validation of the Andon KD-5917 automatic upper arm blood pressure monitor, for clinic use and self-measurement, according to the European Society of Hypertension International Protocol revision 2010. Blood Press Monit. 2014 Aug;19(4):242-5. doi: 10.1097/MBP.0000000000000048. PMID: 24847724.
ESH-IP:2010 - Pass General population
Andon KD-595
Wu N, Zhang X, Wang W, Zhang H. Validation of the Andon KD-595 for clinical use and self-measurement according to the European Society of Hypertension International Protocol. Blood Press Monit. 2016 Apr;21(2):124-7. Epub: 2015 Nov. doi: 10.1097/MBP.0000000000000164. PMID: 26544523.
ESH-IP:2010 - Pass General population
Liu K, Wu D, Bing S, Li LY. Validation of the ANDON KD-595 automated upper-arm blood pressure monitor according to the universal standard. Blood Press Monit. 2024 Apr 1;29(2):103-106. Epub: 2023 Dec 14. doi: 10.1097/MBP.0000000000000686. PMID: 38193382.
81060-2:2019 - Pass General population
Andon KD-5965
Huang J, Li Z, Li G, Liu Z. Validation of the Andon KD-5965 upper-arm blood pressure monitor for home blood pressure monitoring according to the European Society of Hypertension International Protocol revision 2010. Blood Press Monit. 2015 Oct;20(5):283-5. Epub: 2015 May 5. doi: 10.1097/MBP.0000000000000129. PMID: 25968093.
ESH-IP:2010 - Pass General population
Beurer BM 44
Lüders S, Krüger R, Zemmrich C, Forstner K, Sturm CD, Bramlage P. Validation of the Beurer BM 44 upper arm blood pressure monitor for home measurement, according to the European Society of Hypertension International Protocol 2002. Blood Press Monit. 2012 Dec;17(6):248-52. doi: 10.1097/MBP.0b013e32835b9e8e. PMID: 23147534.
ESH-IP:2002 General population (Note: ESH-02 not recognised since 01 July 2011)
iHealth Track (KN-550BT)
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)
Shi L, Zhang XY, Sun JY, Chen JF, Ma YF, Zhou KY. Validation of the iHealth Track upper-arm blood pressure monitor KN-550BT in general population according to the AAMI/ESH/ISO Universal Standard (ISO 81060-2:2018+AMD1:2020). Blood Press Monit. 2024 Feb 1;29(1):41-44. Epub: 2023 Sep 14. doi: 10.1097/MBP.0000000000000678 . PMID: 37702596.
81060-2:2020 - Pass General population