Cleared Traditional

Transtek Blood Pressure Monitor (K181832) - FDA 510(k) Clearance

Also marketed or referenced as:
Welch Allyn 901123 Digital Blood Pressure Device

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

K181832 · Guangdong Transtek Medical Electronics Co., Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2019
Decision
274d
Days
Class 2
Risk

K181832 is an FDA 510(k) clearance for the Transtek Blood Pressure Monitor. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Guangdong Transtek Medical Electronics Co., Ltd. (Zhongshan, CN). The FDA issued a Cleared decision on April 9, 2019 after a review of 274 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.

View all Guangdong Transtek Medical Electronics Co., Ltd. devices

Submission Details

510(k) Number K181832 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 09, 2018
Decision Date April 09, 2019
Days to Decision 274 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
149d slower than avg
Panel avg: 125d · This submission: 274d
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.

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

All 269
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K181832.
TOF-Cuff monitor
K181894 · Rgb Medical Devices SA · May 2019
A&D Medical Blood Pressure Monitors
K173065 · A&D Company, Ltd. · Apr 2019
HEM-6410T-ZL Wrist Blood Pressure Monitor
K190693 · Omron Healthcare, Inc. · Apr 2019
GMC Upper Arm Automatic Blood Pressure Monitor
K181931 · Gmc, Inc. · Apr 2019
Arm Blood Pressure Monitor
K183491 · Xuzhou Yongkang Electronic Science Technology Co., Ltd. · Mar 2019
A&D Medical Blood Pressure Monitors
K173191 · A&D Company, Ltd. · Mar 2019