Cleared Traditional

K122976 - BODY FAT SCALE MODEL SF-371 (FDA 510(k) Clearance)

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

K122976 · Shenzhen Belter Health Measurement and Analysis TE · Gastroenterology & Urology device
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Jan 2013
Decision
100d
Days
Class 2
Risk

K122976 is an FDA 510(k) clearance for the BODY FAT SCALE MODEL SF-371. Classified as Analyzer, Body Composition (product code MNW), Class II - Special Controls.

Submitted by Shenzhen Belter Health Measurement and Analysis TE (Echo, US). The FDA issued a Cleared decision on January 4, 2013 after a review of 100 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 Shenzhen Belter Health Measurement and Analysis TE devices

Submission Details

510(k) Number K122976 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 2012
Decision Date January 04, 2013
Days to Decision 100 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
30d faster than avg
Panel avg: 130d · This submission: 100d
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.