Cleared Traditional

ROWENTA INC. BODYPARTNER VISION, MODEL BM 210 (2079565620) (K023429) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K023429 · Rowenta, Inc. · Gastroenterology & Urology device
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Sep 2003
Decision
347d
Days
Class 2
Risk

K023429 is an FDA 510(k) clearance for the ROWENTA INC. BODYPARTNER VISION, MODEL BM 210 (2079565620). Classified as Analyzer, Body Composition (product code MNW), Class II - Special Controls.

Submitted by Rowenta, Inc. (Medford, US). The FDA issued a Cleared decision on September 23, 2003 after a review of 347 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: Standard predicate-based submission. Elevated predicate reliance profile. 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 Rowenta, Inc. devices

Submission Details

510(k) Number K023429 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 11, 2002
Decision Date September 23, 2003
Days to Decision 347 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
217d slower than avg
Panel avg: 130d · This submission: 347d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.