# K032610: Modified Sonamet Body Composition Analyzer

- Pathway: 510(k) (Abbreviated)
- Applicant: Life Measurement, Inc.
- Decided: Mar 1, 2004 after 189 days
- Product code: OAC (Plethysmograph, Air Displacement For Body Composition Analysis)
- Device class: 2
- Regulation: 21 CFR 870.2770
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K902042 (1990). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K924972: Sonamet Body Composition Analyzer, Life Measurement Instruments, Inc. (1995) Summary page 2.
- K902042: EM-Scan HP-2 Pediatric Body Composition Analyzer, Em-Scan, Inc. (1990) Summary page 2.

## Indications for use
The modified Sonamet Body Composition Analyzer, also known as the PEA POD ® Infant Body Composition System (the PEA POD), is indicated for measuring body mass and estimating the body composition (i.e., the body fat and lean body mass) of infants between 1 and 8 kilograms. It is not intended for use with infants requiring life support.

Source page: https://510kreport.com/device/K032610
Methodology: https://510kreport.com/methodology