Cleared Traditional

K002835 - BODYSTAT

K002835 is an FDA 510(k) clearance for BODYSTAT, 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 294-day FDA review.

K002835 · Bodystat , Ltd. · Gastroenterology & Urology device
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Jul 2001
Decision
294d
Days
Class 2
Risk

K002835 is an FDA 510(k) clearance for the BODYSTAT. Classified as Analyzer, Body Composition (product code MNW), Class II - Special Controls.

Submitted by Bodystat , Ltd. (British Isles, GB). The FDA issued a Cleared decision on July 3, 2001 after a review of 294 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 Bodystat , Ltd. devices

FDA 510(k) Submission Details - K002835

510(k) Number K002835 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 2000
Decision Date July 03, 2001
Days to Decision 294 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
163d slower than avg
Panel avg: 131d · This submission: 294d
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 66
Devices cleared under the same product code (MNW) and FDA review panel - the closest regulatory comparables to K002835.
WRIST BLOOD PRESSURE MONITOR & FAT METER, MODEL WT-20
K031582 · Nihon Seimitsu Sokki Co., Ltd. · Aug 2003
AVITA BF1 (VITALIO) BODY FAT ANALYZER
K020738 · Avita Corporation · May 2003
BODY FAT ANALYZER, MODEL HBF-306
K011652 · Omron Healthcare, Inc. · Nov 2001
BODYSTAT 1500MDD BODY COMPOSITION MONITORING UNIT
K994242 · Bodystat , Ltd. · Mar 2000
FUTREX-6100/XL
K963271 · Futrex, Inc. · Aug 1998
BODYSTAT DUALSCAN 2005
K980971 · Bodystat , Ltd. · Jun 1998