Cleared Traditional

K014009 - TANITA BODY COMPOSITION ANALYZER

Also marketed or referenced as:
TANITA BODY FAT MONITOR TANITA ULTIMATE SCALE

K014009 is an FDA 510(k) clearance for TANITA BODY COMPOSITION ANALYZER, 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 201-day FDA review.

K014009 · Tanita Corp. of America · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2002
Decision
201d
Days
Class 2
Risk

K014009 is an FDA 510(k) clearance for the TANITA BODY COMPOSITION ANALYZER. Classified as Analyzer, Body Composition (product code MNW), Class II - Special Controls.

Submitted by Tanita Corp. of America (Arlington Heights, US). The FDA issued a Cleared decision on June 24, 2002 after a review of 201 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 Tanita Corp. of America devices

FDA 510(k) Submission Details - K014009

510(k) Number K014009 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 2001
Decision Date June 24, 2002
Days to Decision 201 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
70d slower than avg
Panel avg: 131d · This submission: 201d
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 66
Devices cleared under the same product code (MNW) and FDA review panel - the closest regulatory comparables to K014009.
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
BODYSTAT 1500MDD BODY COMPOSITION MONITORING UNIT
K994242 · Bodystat , Ltd. · Mar 2000
FUTREX-6100/XL
K963271 · Futrex, Inc. · Aug 1998