Cleared Traditional

K060538 - BEAVERITE BODY FAT SCALES

K060538 is an FDA 510(k) clearance for BEAVERITE BODY FAT SCALES, manufactured by Beaverite International Limited. The device is a Class 2 Gastroenterology & Urology device with product code MNW cleared through the Traditional 510(k) pathway after a 224-day FDA review.

K060538 · Beaverite International Limited · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2006
Decision
224d
Days
Class 2
Risk

K060538 is an FDA 510(k) clearance for the BEAVERITE BODY FAT SCALES, MODELS 8901, 8903, 8905, 8909, 8911, 8915, 9563 AN.... Classified as Analyzer, Body Composition (product code MNW), Class II - Special Controls.

Submitted by Beaverite International Limited (Chevy Chase, US). The FDA issued a Cleared decision on October 10, 2006 after a review of 224 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 Beaverite International Limited devices

FDA 510(k) Submission Details - K060538

510(k) Number K060538 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 28, 2006
Decision Date October 10, 2006
Days to Decision 224 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
94d slower than avg
Panel avg: 130d · This submission: 224d
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 8
Devices cleared under the same product code (MNW) and FDA review panel - the closest regulatory comparables to K060538.
Multi-parameter detector
K231116 · Zhongshan Jinli Electronic Weighing? Equipment Co., Ltd. · Jun 2024
WI-FI BODY SCALE
K120896 · Andon Health Co, Ltd. · Jul 2012
BODY COMPOSITION MONITOR WITH SCALE, MODEL HBF-500
K062043 · Omron Healthcare, Inc. · Nov 2006
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
AVITA BF1 (VITALIO) BODY FAT ANALYZER
K020738 · Avita Corporation · May 2003