Cleared Abbreviated

K101681 - TRANSTEK BLOOD PRESSURE MONITOR MODEL T...

K101681 is the FDA 510(k) clearance for TRANSTEK BLOOD PRESSURE MONITOR MODEL T... by Zhongshan Transtek Electronics Co., Ltd.. It is a Class 2 Cardiovascular device (product code DXN) cleared through the Abbreviated 510(k) pathway after a 346-day FDA review.

K101681 · Zhongshan Transtek Electronics Co., Ltd. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
May 2011
Decision
346d
Days
Class 2
Risk

K101681 is an FDA 510(k) clearance for the TRANSTEK BLOOD PRESSURE MONITOR MODEL TMB-986, TMB-987, TMB-995. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Zhongshan Transtek Electronics Co., Ltd. (Chengdu, Sichuan, CN). The FDA issued a Cleared decision on May 27, 2011 after a review of 346 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1130 - the FDA cardiovascular device oversight framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Zhongshan Transtek Electronics Co., Ltd. devices

Submission Details

510(k) Number K101681 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 15, 2010
Decision Date May 27, 2011
Days to Decision 346 days
Submission Type Abbreviated
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
221d slower than avg
Panel avg: 125d · This submission: 346d
Pathway characteristics
Standards-based clearance path.

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

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