Cleared Traditional

K101807 - STAYHEALTHY BODY COMPOSITION MONITOR-BCM (FDA 510(k) Clearance)

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

K101807 · Stayhealthy, Inc. · Gastroenterology & Urology device
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Jan 2011
Decision
212d
Days
Class 2
Risk

K101807 is an FDA 510(k) clearance for the STAYHEALTHY BODY COMPOSITION MONITOR-BCM. Classified as Analyzer, Body Composition (product code MNW), Class II - Special Controls.

Submitted by Stayhealthy, Inc. (Monrovia, US). The FDA issued a Cleared decision on January 26, 2011 after a review of 212 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 Stayhealthy, Inc. devices

Submission Details

510(k) Number K101807 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 28, 2010
Decision Date January 26, 2011
Days to Decision 212 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
82d slower than avg
Panel avg: 130d · This submission: 212d
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.