Cleared Special

K123781 - TRANSTEK GLASS BODY FAT ANALYZER

K123781 is an FDA 510(k) clearance for TRANSTEK GLASS BODY FAT ANALYZER, 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 30-day FDA review.

K123781 · 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
Jan 2013
Decision
30d
Days
Class 2
Risk

K123781 is an FDA 510(k) clearance for the TRANSTEK GLASS BODY FAT ANALYZER. 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 January 9, 2013 after a review of 30 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 - K123781

510(k) Number K123781 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 10, 2012
Decision Date January 09, 2013
Days to Decision 30 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
101d faster than avg
Panel avg: 131d · This submission: 30d
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 K123781.
TRANSTEK BODY FAT ANALYZER
K130311 · Guangdong Transtek Medical Electronics Co., Ltd. · May 2013
SECA MEDICAL BODY COMPOSTION ANALYZER 514, SECA MBCA 514, SECA MBCA, SECA 514
K122388 · Seca GmbH & Co. KG · May 2013
INBODY 770, INBODY 570, INBODY S10, INBODY H20/INBODY H20(B)
K123228 · Biospace Corporation Limited · Mar 2013
BODY FAT SCALE MODEL SF-371
K122976 · Shenzhen Belter Health Measurement and Analysis TE · Jan 2013
WITHINGS, SMART BODY SCALE
K121971 · Zhongshan Transtek Electronics Co., Ltd. · Sep 2012
WI-FI BODY SCALE
K120896 · Andon Health Co, Ltd. · Jul 2012
K123781 · TRANSTEK GLASS BODY FAT ANALYZER
Download PDF FDA Summary Zhongshan Transtek El…