Cleared Traditional

K023817 - SMARTSHAPE BODY COMPOSITION ANALYZER, MODEL 4010

K023817 is an FDA 510(k) clearance for SMARTSHAPE BODY COMPOSITION ANALYZER, manufactured by Clio Designs, Inc.. 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.

K023817 · Clio Designs, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2003
Decision
222d
Days
Class 2
Risk

K023817 is an FDA 510(k) clearance for the SMARTSHAPE BODY COMPOSITION ANALYZER, MODEL 4010. Classified as Analyzer, Body Composition (product code MNW), Class II - Special Controls.

Submitted by Clio Designs, Inc. (Watertown, US). The FDA issued a Cleared decision on June 25, 2003 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 Clio Designs, Inc. devices

FDA 510(k) Submission Details - K023817

510(k) Number K023817 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 15, 2002
Decision Date June 25, 2003
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 76
Devices cleared under the same product code (MNW) and FDA review panel - the closest regulatory comparables to K023817.
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