Cleared Traditional

K023478 - INBODY AP1 BODY COMPOSITION ANALYZER

K023478 is an FDA 510(k) clearance for INBODY AP1 BODY COMPOSITION ANALYZER, manufactured by Biospace Co.,Ltd. The device is a Class 2 Gastroenterology & Urology device with product code MNW cleared through the Traditional 510(k) pathway after a 209-day FDA review.

K023478 · Biospace Co.,Ltd · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2003
Decision
209d
Days
Class 2
Risk

K023478 is an FDA 510(k) clearance for the INBODY AP1 BODY COMPOSITION ANALYZER. Classified as Analyzer, Body Composition (product code MNW), Class II - Special Controls.

Submitted by Biospace Co.,Ltd (Deer Field, US). The FDA issued a Cleared decision on May 13, 2003 after a review of 209 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 Biospace Co.,Ltd devices

FDA 510(k) Submission Details - K023478

510(k) Number K023478 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 16, 2002
Decision Date May 13, 2003
Days to Decision 209 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
78d slower than avg
Panel avg: 131d · This submission: 209d
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 76
Devices cleared under the same product code (MNW) and FDA review panel - the closest regulatory comparables to K023478.
WRIST BLOOD PRESSURE MONITOR & FAT METER, MODEL WT-20
K031582 · Nihon Seimitsu Sokki Co., Ltd. · Aug 2003
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K023817 · Clio Designs, Inc. · Jun 2003
AVITA BF1 (VITALIO) BODY FAT ANALYZER
K020738 · Avita Corporation · 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
CLOCKMINI, MODEL DF301
K023942 · Yamato Corp. · Feb 2003