Cleared Traditional

K261394 - 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 is an FDA 510(k) clearance for Arm-type Fully Automatic Digital Blood ..., manufactured by Joytech Healthcare Co. , Ltd.. The device is a Class 2 Cardiovascular device with product code DXN cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K261394 · Joytech Healthcare Co. , Ltd. · Cardiovascular device

Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)

Optimized for regulatory review, auditing and printing

Aug 2026

Decision

119d

Days

Class 2

Risk

K261394 is an FDA 510(k) clearance for the Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6186 Plus, DBP-6.... Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Joytech Healthcare Co. , Ltd. (Hangzhou, CN). The FDA issued a Cleared decision on August 26, 2026 after a review of 119 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.

FDA 510(k) Submission Details - K261394

510(k) Number	K261394 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	April 29, 2026
Decision Date	August 26, 2026
Days to Decision	119 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

6d faster than avg

Panel avg: 125d · This submission: 119d

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 1206

Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K261394.

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)

K260470 · Shenzhen Brav Electronic Technologies Co., Ltd. · Oct 2026

Upper Arm Blood pressure monitor (BP7155D)

K261929 · Omron Healthcare, Inc. · Sep 2026

Happy Health Blood Pressure Monitor

K254000 · Happy Health, Inc. · Sep 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

Microlife Wrist Blood Pressure Monitor , (Model BPHJG5-G)

K261082 · Microlife Corporation · Jul 2026

FDA 510(k) Resources - Cardiovascular

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.