Cleared Traditional

K062043 - BODY COMPOSITION MONITOR WITH SCALE, MODEL HBF-500

K062043 is an FDA 510(k) clearance for BODY COMPOSITION MONITOR WITH SCALE, manufactured by Omron Healthcare, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code MNW cleared through the Traditional 510(k) pathway after a 111-day FDA review.

K062043 · Omron Healthcare, Inc. · Gastroenterology & Urology device
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Nov 2006
Decision
111d
Days
Class 2
Risk

K062043 is an FDA 510(k) clearance for the BODY COMPOSITION MONITOR WITH SCALE, MODEL HBF-500. Classified as Analyzer, Body Composition (product code MNW), Class II - Special Controls.

Submitted by Omron Healthcare, Inc. (Bonita Springs, US). The FDA issued a Cleared decision on November 7, 2006 after a review of 111 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 Omron Healthcare, Inc. devices

FDA 510(k) Submission Details - K062043

510(k) Number K062043 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 19, 2006
Decision Date November 07, 2006
Days to Decision 111 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
20d faster than avg
Panel avg: 131d · This submission: 111d
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 K062043.
HUIBAO BODY FAT SCALE
K111404 · Zhongshan Huibao Weighing Apparatus Co., Ltd. · Oct 2011
INBODY
K110689 · Biospace Corporation Limited · Aug 2011
BODY ANALYSIS SCALE, MODEL BG 17
K110928 · Shenzhen Healthcare Electronic Technology Co., Ltd. · Jul 2011
BIODYNAMICS BIA 500 BIOMPEDANCE BODY COMPOSITION ANALYZER
K051675 · Biodynamics Corp. · Mar 2006
SLIMMANAGER, MODEL SM-X, SM-E
K051589 · Aiia Communication, Inc. · Oct 2005
IMPEDIMED - BODY COMPOSITION ANALYSIS
K050395 · Impedimed Pty , Ltd. · Jul 2005