Cleared Special

K121971 - WITHINGS

K121971 is the FDA 510(k) clearance for WITHINGS by Zhongshan Transtek Electronics Co., Ltd.. It is a Class 2 Gastroenterology & Urology device (product code MNW) cleared through the Special 510(k) pathway after a 84-day FDA review.

K121971 · Zhongshan Transtek Electronics Co., Ltd. · Gastroenterology & Urology device
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Sep 2012
Decision
84d
Days
Class 2
Risk

K121971 is an FDA 510(k) clearance for the WITHINGS, SMART BODY SCALE. 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 September 27, 2012 after a review of 84 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.

View all Zhongshan Transtek Electronics Co., Ltd. devices

Submission Details

510(k) Number K121971 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 05, 2012
Decision Date September 27, 2012
Days to Decision 84 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
46d faster than avg
Panel avg: 130d · This submission: 84d
Pathway characteristics
Modification to existing cleared device.

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 K121971.
Multi-parameter detector
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K062043 · Omron Healthcare, Inc. · Nov 2006
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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