Cleared Traditional

K053556 - BODY COMPOSITION ANALYZER, MODELS ZEUS 9.9 AND VENUS 5.5

K053556 is an FDA 510(k) clearance for BODY COMPOSITION ANALYZER, manufactured by Jawon Medical Co., Ltd.. The device is a Class 2 Gastroenterology & Urology device with product code MNW cleared through the Traditional 510(k) pathway after a 254-day FDA review.

K053556 · Jawon Medical Co., Ltd. · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2006
Decision
254d
Days
Class 2
Risk

K053556 is an FDA 510(k) clearance for the BODY COMPOSITION ANALYZER, MODELS ZEUS 9.9 AND VENUS 5.5. Classified as Analyzer, Body Composition (product code MNW), Class II - Special Controls.

Submitted by Jawon Medical Co., Ltd. (Seoul, Korea, KR). The FDA issued a Cleared decision on August 31, 2006 after a review of 254 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.

FDA 510(k) Submission Details - K053556

510(k) Number K053556 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 2005
Decision Date August 31, 2006
Days to Decision 254 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
123d slower than avg
Panel avg: 131d · This submission: 254d
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 K053556.
INNERSCAN BODY COMPOSITION MONITOR, INNERSCAN SEGMENTAL BODY COMPOSITION MONITOR
K062652 · Tanita Corporation of America · Dec 2006
BODY COMPOSITION MONITOR WITH SCALE, MODEL HBF-500
K062043 · Omron Healthcare, Inc. · Nov 2006
BEAVERITE BODY FAT SCALES, MODELS 8901, 8903, 8905, 8909, 8911, 8915, 9563 AND 9568
K060538 · Beaverite International Limited · Oct 2006
DUTECK BODY COMPOSITION ANALYZER
K060642 · Duteck Industrial Co., Ltd. · Jun 2006
BC100 BODY COMPOSITION ANALYSIS SYSTEM
K060552 · Athletic Iq, Inc. · May 2006
IMPEDIMED - BODY COMPOSITION ANALYZER, MODEL IMP SFB7
K052319 · Impedimed Pty , Ltd. · Apr 2006
K053556 · BODY COMPOSITION ANALYZER, MODELS ZEUS 9.9 AND VENUS 5.5
Download PDF FDA Summary Jawon Medical Co., Lt…