Cleared Traditional

K052319 - IMPEDIMED - BODY COMPOSITION ANALYZER, MODEL IMP SFB7

K052319 is an FDA 510(k) clearance for IMPEDIMED - BODY COMPOSITION ANALYZER, manufactured by Impedimed Pty , Ltd.. The device is a Class 2 Gastroenterology & Urology device with product code MNW cleared through the Traditional 510(k) pathway after a 222-day FDA review.

K052319 · Impedimed Pty , Ltd. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2006
Decision
222d
Days
Class 2
Risk

K052319 is an FDA 510(k) clearance for the IMPEDIMED - BODY COMPOSITION ANALYZER, MODEL IMP SFB7. Classified as Analyzer, Body Composition (product code MNW), Class II - Special Controls.

Submitted by Impedimed Pty , Ltd. (Brisbane, Queensland, AU). The FDA issued a Cleared decision on April 4, 2006 after a review of 222 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 Impedimed Pty , Ltd. devices

FDA 510(k) Submission Details - K052319

510(k) Number K052319 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 25, 2005
Decision Date April 04, 2006
Days to Decision 222 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
91d slower than avg
Panel avg: 131d · This submission: 222d
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 65
Devices cleared under the same product code (MNW) and FDA review panel - the closest regulatory comparables to K052319.
BODY COMPOSITION ANALYZER, MODELS ZEUS 9.9 AND VENUS 5.5
K053556 · Jawon Medical Co., Ltd. · Aug 2006
DUTECK BODY COMPOSITION ANALYZER
K060642 · Duteck Industrial Co., Ltd. · Jun 2006
BC100 BODY COMPOSITION ANALYSIS SYSTEM
K060552 · Athletic Iq, Inc. · May 2006
BIODYNAMICS BIA 500 BIOMPEDANCE BODY COMPOSITION ANALYZER
K051675 · Biodynamics Corp. · Mar 2006
AQ-830 SLIM BODY, BODY FAT MONITOR
K052678 · Limax Electronics Co., Ltd. · Dec 2005
BIOSPACE BODY COMPOSITION ANALYZERS, MODELS INBODY 520, 720 AND S20
K052646 · Biospace Corporation Limited · Dec 2005