Cleared Abbreviated

K251113 - iHealth Compare Wireless Blood Pressure Monitor(BP-300C) (FDA 510(k) Clearance)

Also includes:
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

Class II Cardiovascular device cleared through the Abbreviated 510(k) pathway.

K251113 · Andon Health Co, Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2025
Decision
115d
Days
Class 2
Risk

K251113 is an FDA 510(k) clearance for the iHealth Compare Wireless Blood Pressure Monitor(BP-300C). Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Andon Health Co, Ltd. (Tianjin, CN). The FDA issued a Cleared decision on August 4, 2025 after a review of 115 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1130 - the FDA cardiovascular device oversight framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Andon Health Co, Ltd. devices

Submission Details

510(k) Number K251113 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
10d faster than avg
Panel avg: 125d · This submission: 115d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code DXN System, Measurement, Blood-pressure, Non-invasive
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1130
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Cardiovascular devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT05551845 Completed Observational Industry-sponsored

Blood Pressure Monitor Clinical Test (Cuff Range: 15-24,20-34,30-44,22-42）

Blood Pressure Monitor（Model：KD-595） Clinical Test

90
Patients (actual)
1
Site
Condition studied Blood Pressure
Eligibility All sexes · 12 Years+ · Healthy volunteers accepted
Sponsor Andon Health Co., Ltd (industry)
Started 2021-04-07 → Primary completion 2021-06-30 → Completed 2022-03-01
Primary outcome
blood pressure monitor accuracy
Study completed - no results published. This trial concluded in 2022 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished. Individual participant data will not be shared.
View full study on ClinicalTrials.gov

Regulatory Peers - DXN System, Measurement, Blood-pressure, Non-invasive

All 1209
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K251113.
Automatic Digital Blood Pressure Monitor (LD-587, LD-528, LD-562, LD-581, LD-521, LD-527, LD-572 & LD-569)
K260260 · Honsun (Nantong) Co., Ltd. · Apr 2026
Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-62E3B, DBP-62E2B, DBP-62E1B, DBP-61E3, DBP-61E2, DBP-61E1, DBP-61D7G, DBP-6281L, DBP-6282L, DBP-6285L)
K252501 · Joytech Healthcare Co. , Ltd. · Apr 2026
Korotkoff sound blood pressure monitor
K253982 · Beijing Hanvon Health Technology Co., Ltd. · Apr 2026
Arm Blood Pressure Monitor Models: ARM-30C+
K260276 · Shenzhen AOJ Medical Technology Co., Ltd. · Apr 2026
Arm Blood Pressure Monitor (HH-802CB, HH-802EB, HH-805CB, HH-812CB, HH-808CL, HH-808EL)
K254225 · Shenzhen HanHan Technology Co., Ltd. · Apr 2026
Automatic Electronic Blood Pressure Monitor (U90B series models including ( U90B,U90B Pro,U90B Plus,U90B Ultra,U90C,U90C Pro,U90C Plus,U90C Ultra).)
K260273 · Shenzhen Urion Technology Co., Ltd. · Mar 2026