K-number	K251113
Device name	iHealth Compare Wireless Blood Pressure Monitor(BP-300C);iHealth Compare Pro Wireless Blood Pressure Monitor(BP-300CV);iHealth Compare S Wireless Blood Pressure Monitor(BP-300V);iHealth Wireless Blood Pressure Monitor(BPX1);iHealth Blood Pressure Monitor(KD-595);iHealth Track Pro Connected Blood Pressure Monitor(KN-550LT);Semi Automatic Blood Pressure Monitor(KD-388N);Arm Blood Pressure Monitor(KD-553);Arm Blood Pressure Monitor(KD-557BR);Arm Blood Pressure Monitor(KD-558);Arm Blood Pr
Applicant	Andon Health Co, Ltd.
Product code	DXN
Device class	Class II
Decision date	Aug 4, 2025
Decision	Substantially Equivalent
Regulation	870.1130

AI Summary extracted from FDA summary PDF · never regenerated

Intended use

This is a fully automatic electronic blood pressure monitor for use by medical professionals or at home. It non-invasively measures systolic and diastolic blood pressures and pulse rate using an inflatable cuff wrapped around the upper arm, with cuff circumference limited to 15–48 cm. The device uses oscillometric measurement technology with a silicon integrated pressure sensor.

Technological characteristics

Subject devices differ from the predicate (KD-5811BT) in cuff range (15–48 cm vs. 17–42 cm), memory capacity, display features, electrical power specifications, battery types, and some measurement processes (some measure during deflation, others during inflation). Core performance parameters including pulse rate range (40–180 bpm), pressure accuracy (±3 mmHg), and oscillometric algorithm remain identical.

Test standards cited

IEC 60601-1:2005+AMD1:2012+AMD2:2020 (general electrical safety), IEC 60601-1-2:2014+AMD1:2020 (EMC requirements), IEC 60601-1-11:2015+AMD1:2020 (home healthcare environment), IEC 80601-2-30:2018 (non-invasive sphygmomanometer requirements), and ISO 81060-2:2018+Amd-1:2020 (clinical validation).

Substantial equivalence argument

The devices share identical intended use, design principle, oscillometric measurement method, performance parameters, and applicable standards as the predicate. Differences in cuff range, memory, display information, and electrical power are non-core features validated through electrical safety, EMC, and software testing to not raise new safety or effectiveness concerns. A clinical study of 231 patients demonstrated accuracy meeting ISO 81060-2 criteria 1 and 2, establishing equivalence to the predicate device.

Extracted by AI from the official FDA summary PDF →

Source

View the full FDA submission: accessdata.fda.gov

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