Cleared Traditional

Blood Pressure Monitor (K202891) - FDA 510(k) Clearance

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

K202891 · Guangdong Transtek Medical Electronics Co., Ltd. · Cardiovascular device
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Mar 2021
Decision
162d
Days
Class 2
Risk

K202891 is an FDA 510(k) clearance for the 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 March 9, 2021 after a review of 162 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 K202891 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 2020
Decision Date March 09, 2021
Days to Decision 162 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
37d slower than avg
Panel avg: 125d · This submission: 162d
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 Consultant

Chonconn Medical Device Consulting Co., Ltd.
Kevin Wang

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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 K202891.
CONTEC08A Electronic Sphygmomanometer, CONTEC08C Electronic Sphygmomanometer, ABPM50 Automatic Blood Pressure Monitor
K202757 · Contec Medical Systems Co.,Ltd · Apr 2021
Microlife Upper Arm Automatic Digital Blood Pressure Monitor
K202729 · Microlife Intellectual Property GmbH · Apr 2021
Omron Model BP7900 Blood Pressure Monitor + EKG
K202228 · Omron Healthcare, Inc. · Apr 2021
Meditech ABPM-06 (BP6)
K201332 · Meditech , Ltd. · Feb 2021
Wrist Electronic Sphygmomanometer
K193386 · Shenzhen Changkun Technology Co., Ltd. · Jan 2021
Arm Electronic Sphygmomanometer
K193387 · Shenzhen Changkun Technology Co., Ltd. · Jan 2021