Cleared Special

K052646 - BIOSPACE BODY COMPOSITION ANALYZERS, MODELS INBODY 520, 720 AND S20

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

K052646 · Biospace Corporation Limited · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K052646

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 131d · This submission: 81d
Pathway characteristics
Modification to existing cleared device.

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 78
Devices cleared under the same product code (MNW) and FDA review panel - the closest regulatory comparables to K052646.
IMPEDIMED - BODY COMPOSITION ANALYZER, MODEL IMP SFB7
K052319 · Impedimed Pty , Ltd. · Apr 2006
BIODYNAMICS BIA 500 BIOMPEDANCE BODY COMPOSITION ANALYZER
K051675 · Biodynamics Corp. · Mar 2006
AQ-830 SLIM BODY, BODY FAT MONITOR
K052678 · Limax Electronics Co., Ltd. · Dec 2005
STAYHEALTHY BODY COMPOSITION ANALYZER, MODELS BC1 AND BC2
K052522 · Stayhealthy, Inc. · Dec 2005
SLIMMANAGER, MODEL SM-X, SM-E
K051589 · Aiia Communication, Inc. · Oct 2005
IMPEDIMED - BODY COMPOSITION ANALYSIS
K050395 · Impedimed Pty , Ltd. · Jul 2005
K052646 · BIOSPACE BODY COMPOSITION ANALYZERS, MODELS INBODY 520, 720 AND S20
Download PDF FDA Summary Biospace Corporation …