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

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

Other: InBody Co. Ltd., InBody Building, 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 (InBody BPBIO480KV) is an automatic blood pressure monitor. Its blood pressure measurement technology has been proven to be accurate, with a 3-star Medaval rating. Blood pressure measurements are taken from the upper arm. It is intended for professional use.
Assessment:
The technology used in the KOROT P3 Accurate (InBody BPBIO480KV), to measure blood pressure, is among the best rated for accuracy by Medaval Ltd. It has passed in two clinical validation studies, between general and specific populations, according to recognised standard protocols, as published in peer-reviewed publications.
Recommendations:
Accuracy AssessmentRecommendationBasis
BP Medaval ★★★ Recommendation Recent clinical validation; recent protocol; multiple clinical validations
BP Stride BP Office use for adults (Unavailable) (Preferred) Published evidence
BP FDA (US) 510(k) 510(k) K221764
Device Family:
InBody BP170P, InBody BP170BP, KOROT P3 Accurate (InBody BPBIO480KV)F
Legend: P Stride Equivalence, F FDA 510(k)
Validation Publications:

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).

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. 2024 Sep 1;42(9):1538-1543. Epub: 2024 Apr 25. 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

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