Cleared Traditional

K994242 - BODYSTAT 1500MDD BODY COMPOSITION MONITORING UNIT

K994242 is an FDA 510(k) clearance for BODYSTAT 1500MDD BODY COMPOSITION MONIT..., manufactured by Bodystat , Ltd.. The device is a Class 2 Gastroenterology & Urology device with product code MNW cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K994242 · Bodystat , Ltd. · Gastroenterology & Urology device
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Mar 2000
Decision
90d
Days
Class 2
Risk

K994242 is an FDA 510(k) clearance for the BODYSTAT 1500MDD BODY COMPOSITION MONITORING UNIT. Classified as Analyzer, Body Composition (product code MNW), Class II - Special Controls.

Submitted by Bodystat , Ltd. (British Isles, BR). The FDA issued a Cleared decision on March 15, 2000 after a review of 90 days - within the typical 510(k) review window.

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 Bodystat , Ltd. devices

FDA 510(k) Submission Details - K994242

510(k) Number K994242 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 1999
Decision Date March 15, 2000
Days to Decision 90 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 131d · This submission: 90d
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 K994242.
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K011652 · Omron Healthcare, Inc. · Nov 2001
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BODYSTAT
K971554 · Bodystat , Ltd. · Nov 1997