Cleared Traditional

K011652 - BODY FAT ANALYZER, MODEL HBF-306

K011652 is an FDA 510(k) clearance for BODY FAT ANALYZER, 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 162-day FDA review.

K011652 · Omron Healthcare, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2001
Decision
162d
Days
Class 2
Risk

K011652 is an FDA 510(k) clearance for the BODY FAT ANALYZER, MODEL HBF-306. Classified as Analyzer, Body Composition (product code MNW), Class II - Special Controls.

Submitted by Omron Healthcare, Inc. (Vernon Hills, US). The FDA issued a Cleared decision on November 7, 2001 after a review of 162 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.

View all Omron Healthcare, Inc. devices

FDA 510(k) Submission Details - K011652

510(k) Number K011652 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 29, 2001
Decision Date November 07, 2001
Days to Decision 162 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
31d slower than avg
Panel avg: 131d · This submission: 162d
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 K011652.
INBODY, MODEL 3.0
K042528 · Biospace Corporation Limited · Jan 2005
WRIST BLOOD PRESSURE MONITOR & FAT METER, MODEL WT-20
K031582 · Nihon Seimitsu Sokki Co., Ltd. · Aug 2003
AVITA BF1 (VITALIO) BODY FAT ANALYZER
K020738 · Avita Corporation · May 2003
BODYSTAT 1500MDD BODY COMPOSITION MONITORING UNIT
K994242 · Bodystat , Ltd. · Mar 2000
FUTREX-6100/XL
K963271 · Futrex, Inc. · Aug 1998
BODYSTAT DUALSCAN 2005
K980971 · Bodystat , Ltd. · Jun 1998