Cleared Abbreviated

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

K251113 · Andon Health Co, Ltd. · Cardiovascular

Aug 2025

Decision

115d

Days

Class 2

Risk

About This 510(k) Submission

K251113 is an FDA 510(k) clearance for the 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, a System, Measurement, Blood-pressure, Non-invasive (Class II — Special Controls, product code DXN), submitted by Andon Health Co, Ltd. (Tianjin, CN). The FDA issued a Cleared decision on August 4, 2025, 115 days after receiving the submission on April 11, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1130.

Submission Details

510(k) Number	K251113 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 11, 2025
Decision Date	August 04, 2025
Days to Decision	115 days
Submission Type	Abbreviated
Review Panel	Cardiovascular (CV)
Summary	Summary PDF