Cleared Abbreviated

K032610 - MODIFIED SONAMET BODY COMPOSITION ANALYZER

K032610 is an FDA 510(k) clearance for MODIFIED SONAMET BODY COMPOSITION ANALYZER, manufactured by Life Measurement, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code OAC cleared through the Abbreviated 510(k) pathway after a 189-day FDA review.

K032610 · Life Measurement, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2004
Decision
189d
Days
Class 2
Risk

K032610 is an FDA 510(k) clearance for the MODIFIED SONAMET BODY COMPOSITION ANALYZER. Classified as Plethysmograph, Air Displacement For Body Composition Analysis (product code OAC), Class II - Special Controls.

Submitted by Life Measurement, Inc. (Los Altos, US). The FDA issued a Cleared decision on March 1, 2004 after a review of 189 days - an extended review cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 870.2770 - the FDA obstetrics and gynecology device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Life Measurement, Inc. devices

FDA 510(k) Submission Details - K032610

510(k) Number K032610 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 25, 2003
Decision Date March 01, 2004
Days to Decision 189 days
Submission Type Abbreviated
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
29d slower than avg
Panel avg: 160d · This submission: 189d
Pathway characteristics
Standards-based clearance path.

OAC Device Classification - Class 2, Special Controls

Product Code OAC Plethysmograph, Air Displacement For Body Composition Analysis
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2770
Definition To Measure The Total Body Volume And Weight For Calculating The Estimated Body Composition (total Body Fat And Total Body Lean Mass).
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 Obstetrics & Gynecology devices follow this clearance model.