Cleared Traditional

K261136 - Blood Pressure Monitor (M501,M501A,M502,M502A,M502C,M502D)

K261136 is an FDA 510(k) clearance for Blood Pressure Monitor (M501, manufactured by Guangzhou Daxin Health Technology Co., Ltd.. The device is a Class 2 Cardiovascular device with product code DXN cleared through the Traditional 510(k) pathway after a 107-day FDA review.

K261136 · Guangzhou Daxin Health Technology Co., Ltd. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Jul 2026
Decision
107d
Days
Class 2
Risk

K261136 is an FDA 510(k) clearance for the Blood Pressure Monitor (M501,M501A,M502,M502A,M502C,M502D). Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Guangzhou Daxin Health Technology Co., Ltd. (Guangzhou, CN). The FDA issued a Cleared decision on July 23, 2026 after a review of 107 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 Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Guangzhou Daxin Health Technology Co., Ltd. devices

FDA 510(k) Submission Details - K261136

510(k) Number K261136 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 07, 2026
Decision Date July 23, 2026
Days to Decision 107 days
Submission Type Traditional
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
18d faster than avg
Panel avg: 125d · This submission: 107d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXN Device Classification - Class 2, Special Controls

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. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

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

All 840
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K261136.
Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6194-P,DBP-6294B-P,DBP-6195P,DBP-6295B-P, DBP-6196P,DBP-6296B-P,DBP-61E1-P, DBP-62E1B-P,DBP-62E3B-P,DBP-61E2-P,DBP-62E2B-P,DBP-61E3-P,DBP-6173-P,DBP-6273B-P,DBP-6179-P,DBP-6279B-P)
K253425 · Joytech Healthcare Co. , Ltd. · Aug 2026
BP Go (BPP-855)
K261061 · Wellvii, Inc. · Aug 2026
Microlife Wrist Blood Pressure Monitor , (Model BPHJG5-G)
K261082 · Microlife Corporation · Jul 2026
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K253126 · Shenzhen Ziqing Medical Equipment Co., Ltd. · Jun 2026
VicorderCS (VCS-SYS-1100)
K260693 · 80 Beats Medical GmbH · Jun 2026
Tournicare ARMA Automatic Blood Pressure Monitor (ARMA-08)
K253059 · Tournicare Pty, Ltd. · Jun 2026