Cleared Traditional

BODYMETRIX BX2000 (K082147) - FDA 510(k) Clearance

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

K082147 · Intelametrix, Inc. · Gastroenterology & Urology device
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Mar 2009
Decision
233d
Days
Class 2
Risk

K082147 is an FDA 510(k) clearance for the BODYMETRIX BX2000. Classified as Ultrasonic Body Composition Analyzer (product code OMV), Class II - Special Controls.

Submitted by Intelametrix, Inc. (Livermore, US). The FDA issued a Cleared decision on March 20, 2009 after a review of 233 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 Intelametrix, Inc. devices

Submission Details

510(k) Number K082147 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 2008
Decision Date March 20, 2009
Days to Decision 233 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
103d slower than avg
Panel avg: 130d · This submission: 233d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OMV Ultrasonic Body Composition Analyzer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2770
Definition Intended To Measure Thickness Of A Distinctive Tissue Layer. Indicated To Calculate The Local Thickness Of A Type Of Tissue [fat, Muscle, Bone, Etc.] At A Single Location, Or At Various Locations On The Body And Via Algorithms, Estimate The Amount Of Local Tissue Or Total Body Tissue, Respectively.
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.