Cleared Traditional

K040978 - TANITA SCALE PLUS BODY FAT MONITOR WITH BODY WATER PERCENTAGE

K040978 is an FDA 510(k) clearance for TANITA SCALE PLUS BODY FAT MONITOR WITH..., manufactured by Tanita Corp. of America. The device is a Class 2 Gastroenterology & Urology device with product code MNW cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K040978 · Tanita Corp. of America · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2004
Decision
98d
Days
Class 2
Risk

K040978 is an FDA 510(k) clearance for the TANITA SCALE PLUS BODY FAT MONITOR WITH BODY WATER PERCENTAGE. Classified as Analyzer, Body Composition (product code MNW), Class II - Special Controls.

Submitted by Tanita Corp. of America (Arlington Hgts., US). The FDA issued a Cleared decision on July 22, 2004 after a review of 98 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 Tanita Corp. of America devices

FDA 510(k) Submission Details - K040978

510(k) Number K040978 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 15, 2004
Decision Date July 22, 2004
Days to Decision 98 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
33d faster than avg
Panel avg: 131d · This submission: 98d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 66
Devices cleared under the same product code (MNW) and FDA review panel - the closest regulatory comparables to K040978.
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
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
BODY FAT ANALYZER, MODEL HBF-306
K011652 · Omron Healthcare, Inc. · Nov 2001