Cleared Special

K161886 - Transtek Blood Pressure Monitor, Welch Allyn Remote Monitoring Blood Pressure Device, Welch Allyn Home Blood Pressure Device (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K161886 · Guangdong Transtek Medical Electronics Co., Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2016
Decision
95d
Days
Class 2
Risk

K161886 is an FDA 510(k) clearance for the Transtek Blood Pressure Monitor, Welch Allyn Remote Monitoring Blood Pressure.... 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 October 14, 2016 after a review of 95 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

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

Submission Details

510(k) Number K161886 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 11, 2016
Decision Date October 14, 2016
Days to Decision 95 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
30d faster than avg
Panel avg: 125d · This submission: 95d
Pathway characteristics
Modification to existing cleared device.

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 1209
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K161886.
Automatic Digital Blood Pressure Monitor (LD-587, LD-528, LD-562, LD-581, LD-521, LD-527, LD-572 & LD-569)
K260260 · Honsun (Nantong) Co., Ltd. · Apr 2026
Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-62E3B, DBP-62E2B, DBP-62E1B, DBP-61E3, DBP-61E2, DBP-61E1, DBP-61D7G, DBP-6281L, DBP-6282L, DBP-6285L)
K252501 · Joytech Healthcare Co. , Ltd. · Apr 2026
Korotkoff sound blood pressure monitor
K253982 · Beijing Hanvon Health Technology Co., Ltd. · Apr 2026
Arm Blood Pressure Monitor Models: ARM-30C+
K260276 · Shenzhen AOJ Medical Technology Co., Ltd. · Apr 2026
Arm Blood Pressure Monitor (HH-802CB, HH-802EB, HH-805CB, HH-812CB, HH-808CL, HH-808EL)
K254225 · Shenzhen HanHan Technology Co., Ltd. · Apr 2026
Automatic Electronic Blood Pressure Monitor (U90B series models including ( U90B,U90B Pro,U90B Plus,U90B Ultra,U90C,U90C Pro,U90C Plus,U90C Ultra).)
K260273 · Shenzhen Urion Technology Co., Ltd. · Mar 2026