KOROT P3 Accurate
Device Name:
P3 Accurate
Device Model:
(BPBIO480KV)
Manufacturer:

Former: InBody Co. Ltd., InBody Building, 54 Nonhyeon-ro 2-gil, Gangnam-gu, Seoul 06313, REPUBLIC of KOREA.

Other: KOROT Co. Ltd., 5F, 54 Nonhyeon-ro 2-gil, Gangnam-gu Seoul 06313, REPUBLIC of KOREA.

Measuring functions:
Blood pressure
Primary Client Use:
Intended for professional use
Measurement Site:
Upper Arm
Measurement Occurrence:
Single measurements only
Availability:
Available Currently
Description:
The KOROT P3 Accurate is an automatic blood pressure monitor. Its blood pressure measurement technology has been proven to be accurate. Blood pressure measurements are taken from the upper arm. It is intended for professional use.
Assessment:
The technology used in the KOROT P3 Accurate, to measure blood pressure, has passed in a clinical validation study, in a specific population, according to a recognised standard protocol, as published in a peer-reviewed publication. It has also been declared as being substantially equivalent to that used in another device, according to 510(k), but this is not compliant with (EU) 2017/745 and MEDDEV 2.7/1 rev 4.
Recommendations:
Accuracy AssessmentRecommendationBasis
BP Medaval Recommended in certain condition(s) Validation in specific condition(s). See publications for details.
Device Family:
InBody BP170P, InBody BP170BP, InBody BPBIO480KVF, KOROT P3 AccurateY
Legend: P Stride Equivalence, F FDA 510(k), Y Internal declaration
Validation Publications:

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).

Relevant Publications:

Menti A, Ntineri A, Kyriakoulis KG, Theodosiadi A, Ntousopoulos V, Stathopoulou P, Kollias A, Stergiou GS. Visual assessment of Korotkoff sounds improves the accuracy of a validated professional automated auscultatory blood pressure monitor KOROT P3 Accurate. J Hypertens. Epub: 2024 Apr 26. doi: 10.1097/HJH.0000000000003753. PMID: 38690918.

The visual assessment of Korotkoff sounds generated during automated auscultatory BP measurement by the monitor identifies unreliable readings and further improves the device accuracy.

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.

InBody BP170

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

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

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