Cleared Traditional

K030349 - HEALTHOMETER PROFESSIONAL BODY FAT MONI...

K030349 is an FDA 510(k) clearance for HEALTHOMETER PROFESSIONAL BODY FAT MONI..., manufactured by Bonso Electronics International, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code MNW cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K030349 · Bonso Electronics International, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2003
Decision
88d
Days
Class 2
Risk

K030349 is an FDA 510(k) clearance for the HEALTHOMETER PROFESSIONAL BODY FAT MONITOR AND SCALE, MODELS BFM 940, BFM 945.... Classified as Analyzer, Body Composition (product code MNW), Class II - Special Controls.

Submitted by Bonso Electronics International, Inc. (Washington, US). The FDA issued a Cleared decision on May 2, 2003 after a review of 88 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Bonso Electronics International, Inc. devices

FDA 510(k) Submission Details - K030349

510(k) Number K030349 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 03, 2003
Decision Date May 02, 2003
Days to Decision 88 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
42d faster than avg
Panel avg: 130d · This submission: 88d
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 K030349.
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
BODY FAT ANALYZER, MODEL HBF-306
K011652 · Omron Healthcare, Inc. · Nov 2001
HBF-1000 OMRON BODY COMPOSITION ANALYZER
K963575 · Omron Healthcare, Inc. · Jun 1997