Cleared Traditional

K020738 - AVITA BF1 (VITALIO) BODY FAT ANALYZER

K020738 is an FDA 510(k) clearance for AVITA BF1 (VITALIO) BODY FAT ANALYZER, manufactured by Avita Corporation. The device is a Class 2 Gastroenterology & Urology device with product code MNW cleared through the Traditional 510(k) pathway after a 442-day FDA review.

K020738 · Avita Corporation · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2003
Decision
442d
Days
Class 2
Risk

K020738 is an FDA 510(k) clearance for the AVITA BF1 (VITALIO) BODY FAT ANALYZER. Classified as Analyzer, Body Composition (product code MNW), Class II - Special Controls.

Submitted by Avita Corporation (Flagstaff, US). The FDA issued a Cleared decision on May 22, 2003 after a review of 442 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Gastroenterology & Urology submissions.

FDA 510(k) Submission Details - K020738

510(k) Number K020738 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 06, 2002
Decision Date May 22, 2003
Days to Decision 442 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
311d slower than avg
Panel avg: 131d · This submission: 442d
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 78
Devices cleared under the same product code (MNW) and FDA review panel - the closest regulatory comparables to K020738.
ROWENTA INC. BODYPARTNER VISION, MODEL BM 210 (2079565620)
K023429 · Rowenta, Inc. · Sep 2003
WRIST BLOOD PRESSURE MONITOR & FAT METER, MODEL WT-20
K031582 · Nihon Seimitsu Sokki Co., Ltd. · Aug 2003
SMARTSHAPE BODY COMPOSITION ANALYZER, MODEL 4010
K023817 · Clio Designs, Inc. · Jun 2003
INBODY AP1 BODY COMPOSITION ANALYZER
K023478 · Biospace Co.,Ltd · May 2003
HEALTHOMETER PROFESSIONAL BODY FAT MONITOR AND SCALE, MODELS BFM 940, BFM 945 & BFM 960
K030349 · Bonso Electronics International, Inc. · May 2003
LONG WELL LW-6DXX SERIES BODY FAT ANALYZER
K030203 · Long Well Electronics Corp. · Apr 2003
K020738 · AVITA BF1 (VITALIO) BODY FAT ANALYZER
Download PDF FDA Summary Avita Corporation