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Andon KD-5001
Device Model:
KD-5001
Manufacturer:
Andon Health Co. Ltd., 3 Jinping Road, Ya'an Street, Nankai District, Tianjin 300190, CHINA.
Measuring functions:
Blood pressure
Primary Client Use:
Intended for self-measurement and home use
Measurement Site:
Upper Arm
Measurement Occurrence:
Single measurements only
Availability:
Discontinued but still available
Description:
The Andon KD-5001 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 upper arm. It is intended for self-measurement and home use. This device has been discontinued by the manufacturer but may be available through certain outlets.
Assessment:
While the technology used in the Andon KD-5001, to measure blood pressure, has been declared as being equivalent to that used in a clinically validated device, no evidence has been published to show that the devices have been compared according to a protocol compliant 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 BIHS (UK and IRL) Self-measurement (Previous) Manufacturer declaration of equivalence to the Andon KD-5915
BP ESH (Europe) Self-measurement The BIHS recommendation, despite the absence, at the time, of the scientific evidence required by the same authors' criteria.
Device Family:
Andon BM-091B, Andon KD-5031D, Andon KD-556D, Andon KD-557B, Andon KD-558 (V1)B, Andon KD-5901 (V1)B, Andon KD-5902B, Andon KD-5905B, Andon KD-5909B, Andon KD-5915 (V1)B,D, Andon KD-5917B, Andon KD-5918B, Andon KD-595B, Andon KD-5961B, Andon KD-5962B, Andon KD-5965B,P, Andon KD-5913D, Andon KD-5001B, Andon KD-5963D, Andon KD-5971B,D, Andon KD-5923B,P, Andon KD-558BRP, Andon KD-5920B,P, Andon KD-5810B, Andon KD-5811B, Andon KD-5815B, Beurer BM 44D, Beurer BM 47D, Beurer BM 58D, Beurer BM 65D, Cas KD-595Z, Desa Pharma Tecnico EasyB, iHealth Track (KN-550BT)B,P, Lloyds Betterlife (KD-551)B, Lloyds KD-551B, Medel Check (92187)D, Medel Elite (92125)D, Medinox Compact (BP102, MX86005)B, Medisana BU 535 Voice (51178)Y, Medisana BU 535 (51176)Y, Medisana BU 535 Voice [S] (51179)Y, Medisana BW 335 (51077)Y, Pic Solution Digit SmartD, Pic Solution Digit ExtraD, Salter BPA-9200-GBB, Salter BPA-8200-EUB, Sanitas SBM-43D
Legend: B BIHS Derivative, D DET Equivalence, P Stride Equivalence, Y Internal declaration, Z Almost Certain
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.

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 (V1)

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

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