Cleared Traditional

K250548 - Arm-type Fully Automatic Digital Blood Pressure Monitors (DBP-6286B, DBP-6186) (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K250548 · Joytech Healthcare Co. , Ltd. · Cardiovascular device

Download Printable Device Report (PDF)

Optimized for regulatory review, auditing and printing

Jun 2025

Decision

121d

Days

Class 2

Risk

K250548 is an FDA 510(k) clearance for the Arm-type Fully Automatic Digital Blood Pressure Monitors (DBP-6286B, DBP-6186). 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 June 26, 2025 after a review of 121 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 Joytech Healthcare Co. , Ltd. devices

Submission Details

510(k) Number	K250548 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	February 25, 2025
Decision Date	June 26, 2025
Days to Decision	121 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

4d faster than avg

Panel avg: 125d · This submission: 121d

Pathway characteristics

Predicate-based equivalence. No clinical trials required.

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