Cleared Traditional

K231542 - Digital Blood Pressure Monitor WBP Series

K231542 is an FDA 510(k) clearance for Digital Blood Pressure Monitor WBP Series, manufactured by Weony (Shenzhen) Technology Co., Ltd.. The device is a Class 2 Cardiovascular device with product code DXN cleared through the Traditional 510(k) pathway after a 100-day FDA review.

K231542 · Weony (Shenzhen) Technology Co., Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2023
Decision
100d
Days
Class 2
Risk

K231542 is an FDA 510(k) clearance for the Digital Blood Pressure Monitor WBP Series. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Weony (Shenzhen) Technology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on September 7, 2023 after a review of 100 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 Weony (Shenzhen) Technology Co., Ltd. devices

FDA 510(k) Submission Details - K231542

510(k) Number K231542 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 30, 2023
Decision Date September 07, 2023
Days to Decision 100 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
25d faster than avg
Panel avg: 125d · This submission: 100d
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 566
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K231542.
Boppli Infant Blood Pressure Monitor
K223873 · Pyrames, Inc. · Sep 2023
Wrist Electronic Blood Pressure Monitor(Model FC-BP200, FC-BP201, FC-BP210,FC-BP211, FC-BP220, FC-BP221)
K231367 · Shenzhen Finicare Co., Ltd. · Sep 2023
Arm Blood Pressure Monitor
K230649 · Alicn Medical (Shenzhen), Inc. · Sep 2023
Wrist Type Blood Pressure Monitor (W05,W1101L)
K230409 · Shenzhen Jamr Technology Co., Ltd. · Aug 2023
Arm-type Fully Automatic Digital Blood Pressure Monitor, Wrist-type Fully Automatic Digital Blood Pressure Monitor
K230566 · Joytech Healthcare Co. , Ltd. · Aug 2023
Electronic Blood Pressure Monitor
K230642 · Dongguan Kangweile Electronic Technology Co., Ltd. · Aug 2023