Cleared Traditional

K130311 - TRANSTEK BODY FAT ANALYZER

K130311 is an FDA 510(k) clearance for TRANSTEK BODY FAT ANALYZER, manufactured by Guangdong Transtek Medical Electronics Co., Ltd.. The device is a Class 2 Gastroenterology & Urology device with product code MNW cleared through the Traditional 510(k) pathway after a 111-day FDA review.

K130311 · Guangdong Transtek Medical Electronics Co., Ltd. · Gastroenterology & Urology device
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May 2013
Decision
111d
Days
Class 2
Risk

K130311 is an FDA 510(k) clearance for the TRANSTEK BODY FAT ANALYZER. Classified as Analyzer, Body Composition (product code MNW), Class II - Special Controls.

Submitted by Guangdong Transtek Medical Electronics Co., Ltd. (Chengdu, Sichuan, CN). The FDA issued a Cleared decision on May 30, 2013 after a review of 111 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 870.2770 - the FDA gastroenterology and urology device 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 Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

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

FDA 510(k) Submission Details - K130311

510(k) Number K130311 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 2013
Decision Date May 30, 2013
Days to Decision 111 days
Submission Type Traditional
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
20d faster than avg
Panel avg: 131d · This submission: 111d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 68
Devices cleared under the same product code (MNW) and FDA review panel - the closest regulatory comparables to K130311.
BIA / VITALITY ANALYZER
K130856 · Ipgdx, LLC · Nov 2013
PRECISION ONE LIFECARE
K130952 · Precision One Lifecare, Ltd. · Sep 2013
TRANSTEK GLASS BODY FAT ANALYZER
K131394 · Guangdong Transtek Medical Electronics Co., Ltd. · Sep 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
TRANSTEK GLASS BODY FAT ANALYZER
K123781 · Zhongshan Transtek Electronics Co., Ltd. · Jan 2013