Cleared Special

K112932 - TRANSTEK

K112932 is an FDA 510(k) clearance for TRANSTEK, manufactured by Zhongshan Transtek Electronics Co., Ltd.. The device is a Class 2 Gastroenterology & Urology device with product code MNW cleared through the Special 510(k) pathway after a 29-day FDA review.

K112932 · Zhongshan Transtek Electronics Co., Ltd. · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2011
Decision
29d
Days
Class 2
Risk

K112932 is an FDA 510(k) clearance for the TRANSTEK. Classified as Analyzer, Body Composition (product code MNW), Class II - Special Controls.

Submitted by Zhongshan Transtek Electronics Co., Ltd. (Chengdu, Sichuan, CN). The FDA issued a Cleared decision on November 1, 2011 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 870.2770 - the FDA gastroenterology and urology device 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. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K112932

510(k) Number K112932 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 2011
Decision Date November 01, 2011
Days to Decision 29 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
102d faster than avg
Panel avg: 131d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

MNW Device Classification - Class 2, Special Controls

Product Code MNW Analyzer, Body Composition
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2770
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 Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - MNW Analyzer, Body Composition

All 78
Devices cleared under the same product code (MNW) and FDA review panel - the closest regulatory comparables to K112932.
WI-FI BODY SCALE
K120896 · Andon Health Co, Ltd. · Jul 2012
WI-FI BODY SCALE
K121527 · Shenzhen Healthcare Electronic Technology Co., Ltd. · Jun 2012
WEIGHT AND BODY FAT SCALE SHINE BS0105
K112149 · Shine Overseas Marketing Limited · Apr 2012
BODY ANALYSIS SCALE
K112951 · Shenzhen Healthcare Electronic Technology Co., Ltd. · Nov 2011
HUIBAO BODY FAT SCALE
K111404 · Zhongshan Huibao Weighing Apparatus Co., Ltd. · Oct 2011
INBODY
K110689 · Biospace Corporation Limited · Aug 2011
K112932 · TRANSTEK
Download PDF FDA Summary Zhongshan Transtek El…