Cleared Traditional

SONAMET BODY COMPOSITION ANALYZER (K924972) - FDA 510(k) Clearance

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

K924972 · Life Measurement Instruments, Inc. · Obstetrics & Gynecology device
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Feb 1995
Decision
866d
Days
Class 2
Risk

K924972 is an FDA 510(k) clearance for the SONAMET BODY COMPOSITION ANALYZER. Classified as Plethysmograph, Air Displacement For Body Composition Analysis (product code OAC), Class II - Special Controls.

Submitted by Life Measurement Instruments, Inc. (Davis, US). The FDA issued a Cleared decision on February 13, 1995 after a review of 866 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 870.2770 - the FDA obstetrics and gynecology 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Obstetrics & Gynecology submissions.

View all Life Measurement Instruments, Inc. devices

Submission Details

510(k) Number K924972 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 1992
Decision Date February 13, 1995
Days to Decision 866 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
706d slower than avg
Panel avg: 160d · This submission: 866d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.