Cleared Special

K052646 - BIOSPACE BODY COMPOSITION ANALYZERS

K052646 is the FDA 510(k) clearance for BIOSPACE BODY COMPOSITION ANALYZERS by Biospace Corporation Limited. It is a Class 2 Gastroenterology & Urology device (product code MNW) cleared through the Special 510(k) pathway after a 81-day FDA review.

K052646 · Biospace Corporation Limited · Gastroenterology & Urology device
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Dec 2005
Decision
81d
Days
Class 2
Risk

K052646 is an FDA 510(k) clearance for the BIOSPACE BODY COMPOSITION ANALYZERS, MODELS INBODY 520, 720 AND S20. Classified as Analyzer, Body Composition (product code MNW), Class II - Special Controls.

Submitted by Biospace Corporation Limited (Deer Field, US). The FDA issued a Cleared decision on December 16, 2005 after a review of 81 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 Biospace Corporation Limited devices

Submission Details

510(k) Number K052646 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 2005
Decision Date December 16, 2005
Days to Decision 81 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
49d faster than avg
Panel avg: 130d · This submission: 81d
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 K052646.
Multi-parameter detector
K231116 · Zhongshan Jinli Electronic Weighing? Equipment Co., Ltd. · Jun 2024
WI-FI BODY SCALE
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