Cleared Traditional

K123228 - INBODY 770, INBODY 570, INBODY S10, INBODY H20/INBODY H20(B)

K123228 is an FDA 510(k) clearance for INBODY 770, manufactured by Biospace Corporation Limited. The device is a Class 2 Gastroenterology & Urology device with product code MNW cleared through the Traditional 510(k) pathway after a 144-day FDA review.

K123228 · Biospace Corporation Limited · Gastroenterology & Urology device
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Mar 2013
Decision
144d
Days
Class 2
Risk

K123228 is an FDA 510(k) clearance for the INBODY 770, INBODY 570, INBODY S10, INBODY H20/INBODY H20(B). Classified as Analyzer, Body Composition (product code MNW), Class II - Special Controls.

Submitted by Biospace Corporation Limited (Naples, US). The FDA issued a Cleared decision on March 8, 2013 after a review of 144 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 Biospace Corporation Limited devices

FDA 510(k) Submission Details - K123228

510(k) Number K123228 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 2012
Decision Date March 08, 2013
Days to Decision 144 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
13d slower than avg
Panel avg: 131d · This submission: 144d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 37
Devices cleared under the same product code (MNW) and FDA review panel - the closest regulatory comparables to K123228.
TRANSTEK GLASS BODY FAT ANALYZER
K131394 · Guangdong Transtek Medical Electronics Co., Ltd. · Sep 2013
TRANSTEK BODY FAT ANALYZER
K130311 · Guangdong Transtek Medical Electronics Co., Ltd. · May 2013
SECA MEDICAL BODY COMPOSTION ANALYZER 514, SECA MBCA 514, SECA MBCA, SECA 514
K122388 · Seca GmbH & Co. KG · May 2013
TRANSTEK GLASS BODY FAT ANALYZER
K123781 · Zhongshan Transtek Electronics Co., Ltd. · Jan 2013
BODY FAT SCALE MODEL SF-371
K122976 · Shenzhen Belter Health Measurement and Analysis TE · Jan 2013
WITHINGS, SMART BODY SCALE
K121971 · Zhongshan Transtek Electronics Co., Ltd. · Sep 2012