Cleared Traditional

K042528 - INBODY, MODEL 3.0

K042528 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 116-day FDA review.

K042528 · Biospace Corporation Limited · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2005
Decision
116d
Days
Class 2
Risk

K042528 is an FDA 510(k) clearance for the INBODY, MODEL 3.0. 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 January 11, 2005 after a review of 116 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.

FDA 510(k) Submission Details - K042528

510(k) Number K042528 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 17, 2004
Decision Date January 11, 2005
Days to Decision 116 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
15d faster than avg
Panel avg: 131d · This submission: 116d
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 K042528.
IMPEDIMED - BODY COMPOSITION ANALYSIS
K050395 · Impedimed Pty , Ltd. · Jul 2005
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
TANITA INNERSCAN BODY COMPOSITION MONITOR, MODEL BC-53X (WHERE X=0 TO 9)
K040778 · Tanita Corp. of America · Dec 2004
TANITA SCALE PLUS BODY FAT MONITOR WITH BODY WATER PERCENTAGE
K040978 · Tanita Corp. of America · Jul 2004
TANITA SEGMENTAL BODY COMPOSITION ANALYZER, MODEL BC-418
K033157 · Tanita Corp. of America · Apr 2004
K042528 · INBODY, MODEL 3.0
Download PDF FDA Summary Biospace Corporation …