Cleared Traditional

K092786 - INBODY, MODELS: 270, R20, R20B

K092786 is an FDA 510(k) clearance for INBODY, 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 181-day FDA review.

K092786 · Biospace Corporation Limited · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2010
Decision
181d
Days
Class 2
Risk

K092786 is an FDA 510(k) clearance for the INBODY, MODELS: 270, R20, R20B. 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 10, 2010 after a review of 181 days - an extended review cycle.

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.

FDA 510(k) Submission Details - K092786

510(k) Number K092786 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 10, 2009
Decision Date March 10, 2010
Days to Decision 181 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
50d slower than avg
Panel avg: 131d · This submission: 181d
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 78
Devices cleared under the same product code (MNW) and FDA review panel - the closest regulatory comparables to K092786.
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K101807 · Stayhealthy, Inc. · Jan 2011
ELECTROFLUIDGRAPH
K091369 · Akern USA, LLC · Oct 2009
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K092431 · Jawon Medical Co., Ltd. · Oct 2009
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K090479 · Tanita Corporation of America · Jul 2009
K092786 · INBODY, MODELS: 270, R20, R20B
Download PDF FDA Summary Biospace Corporation …