Cleared Traditional

K130311 - TRANSTEK BODY FAT ANALYZER (FDA 510(k) Clearance)

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

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

Submission Details

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
Regulatory Context
Review time vs. panel average
19d faster than avg
Panel avg: 130d · This submission: 111d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.