Cleared Abbreviated

BOD POD (K060848) - FDA 510(k) Clearance

Class II Obstetrics & Gynecology device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K060848 · Life Measurement, Inc. · Obstetrics & Gynecology device
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Jun 2006
Decision
91d
Days
Class 2
Risk

K060848 is an FDA 510(k) clearance for the BOD POD. Classified as Plethysmograph, Air Displacement For Body Composition Analysis (product code OAC), Class II - Special Controls.

Submitted by Life Measurement, Inc. (Concord, US). The FDA issued a Cleared decision on June 27, 2006 after a review of 91 days - within the typical 510(k) review window.

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

Submission Details

510(k) Number K060848 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 2006
Decision Date June 27, 2006
Days to Decision 91 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
69d faster than avg
Panel avg: 160d · This submission: 91d
Pathway characteristics
Standards-based clearance path.

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.