Cleared Abbreviated

K102191 - TRANSTEK GLASS BODY ANALYZER

Also marketed or referenced as:
TRANSTEK GLASS BODY ANALYZER TRANSTEK GLASS BODY ANALYZER TRANSTEK GLASS BODY ANALYZER

K102191 is an FDA 510(k) clearance for TRANSTEK GLASS BODY ANALYZER, manufactured by Zhongshan Transtek Electronics Co., Ltd.. The device is a Class 2 Gastroenterology & Urology device with product code MNW cleared through the Abbreviated 510(k) pathway after a 272-day FDA review.

K102191 · 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
May 2011
Decision
272d
Days
Class 2
Risk

K102191 is an FDA 510(k) clearance for the TRANSTEK GLASS BODY 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 May 2, 2011 after a review of 272 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 870.2770 - the FDA gastroenterology and urology device 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.

FDA 510(k) Submission Details - K102191

510(k) Number K102191 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 03, 2010
Decision Date May 02, 2011
Days to Decision 272 days
Submission Type Abbreviated
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
141d slower than avg
Panel avg: 131d · This submission: 272d
Pathway characteristics
Standards-based clearance path.

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 K102191.
HUIBAO BODY FAT SCALE
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INBODY
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K110928 · Shenzhen Healthcare Electronic Technology Co., Ltd. · Jul 2011
MODEL MC-180MA MULTI-FREQUENCY BODY COMPOSITION ANALYZER
K100183 · Tanita Corp. · Apr 2011
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K103026 · Ld Technology, LLC · Mar 2011
MODIFICATION TO BODYSTAT 1500MDD BODY COMPOSITION MONITORING UNIT
K082254 · Bodystat , Ltd. · Feb 2011
K102191 · TRANSTEK GLASS BODY ANALYZER
Download PDF FDA Summary Zhongshan Transtek El…