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 the FDA 510(k) clearance for TRANSTEK GLASS BODY ANALYZER by Zhongshan Transtek Electronics Co., Ltd.. It is a Class 2 Gastroenterology & Urology device (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)
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.

View all Zhongshan Transtek Electronics Co., Ltd. devices

Submission Details

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
142d slower than avg
Panel avg: 130d · This submission: 272d
Pathway characteristics
Standards-based clearance path.

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.

Regulatory Peers - MNW Analyzer, Body Composition

All 7
Devices cleared under the same product code (MNW) and FDA review panel - the closest regulatory comparables to K102191.
Multi-parameter detector
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K120896 · Andon Health Co, Ltd. · Jul 2012
BODY COMPOSITION MONITOR WITH SCALE, MODEL HBF-500
K062043 · Omron Healthcare, Inc. · Nov 2006
HL 188 & HL 189 BODY FAT METER
K043414 · Health & Life Co., Ltd. · Feb 2005
OMRON FAT LOSS MONITOR WITH SCALE, MODEL HBF-400
K043060 · Omron Healthcare, Inc. · Jan 2005
BODY FAT ANALYZER, MODEL HBF-306
K011652 · Omron Healthcare, Inc. · Nov 2001