Cleared Traditional

K260670 - YUWELL® Electronic Blood Pressure Monitor

K260670 is an FDA 510(k) clearance for YUWELL Electronic Blood Pressure Monitor, manufactured by Jiangsu Yuyue Medical Equipment& Supply Co., Ltd.. The device is a Class 2 Cardiovascular device with product code DXN cleared through the Traditional 510(k) pathway after a 240-day FDA review.

K260670 · Jiangsu Yuyue Medical Equipment& Supply Co., Ltd. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2026
Decision
240d
Days
Class 2
Risk

K260670 is an FDA 510(k) clearance for the YUWELL® Electronic Blood Pressure Monitor. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Jiangsu Yuyue Medical Equipment& Supply Co., Ltd. (Danyang, CN). The FDA issued a Cleared decision on October 28, 2026 after a review of 240 days - an extended review cycle.

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.

FDA 510(k) Submission Details - K260670

510(k) Number K260670 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 2026
Decision Date October 28, 2026
Days to Decision 240 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
115d slower than avg
Panel avg: 125d · This submission: 240d
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 1208
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K260670.
Electronic Blood Pressure Monitor (BP-204C, BP-204A, BP-215, BP-203C, BP-205A, BP-201C, BP-217, BP-202C, BP-202 BP-205, BP-205B,BP-206)
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Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6186 Plus, DBP-6286B Plus, DBP-61E3 Plus, DBP-61E2 Plus, DBP-62E3B Plus, DBP-62E2B Plus)
K261394 · Joytech Healthcare Co. , Ltd. · Aug 2026
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
K260670 · YUWELL® Electronic Blood Pressure Monitor
Download PDF FDA Summary Jiangsu Yuyue Medical…