510(k) Report

510(k) · Cleared

Cleared

Modified Sonamet Body Composition Analyzer

K032610510(k) AbbreviatedCleared Mar 1, 2004189-day reviewClass II21 CFR 870.2770

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Life Measurement, Inc. · OAC Plethysmograph, Air Displacement For Body Composition Analysis

Cleared on Mar 1, 2004 as substantially equivalent to K924972 (Life Measurement Instruments, Inc., 1995) and 1 other predicate after a 189-day review. Its family tree reaches back 1 generation to 1990.

Decided
Mar 1, 2004
Review
189 days
Class
Class II
Product code
OAC
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K902042 (1990). 2 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1995: 1 other ancestorK902042 · EM-Scan HP-2 Pediatric Body Composition Analyzer · Em-Scan, Inc. · 19901990199520002005
Other ancestors, by generation 1 generation back: 1 other ancestor K902042 · EM-Scan HP-2 Pediatric Body Composition Analyzer · Em-Scan, Inc. · 19900
  1. Root · 1 generation backK902042 EM-Scan HP-2 Pediatric Body Composition AnalyzerEm-Scan, Inc. · 1990
  2. This deviceK032610 Modified Sonamet Body Composition AnalyzerLife Measurement, Inc. · 2004
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K902042EM-Scan HP-2 Pediatric Body Composition AnalyzerEm-Scan, Inc.1990—
0 (this device)K032610Modified Sonamet Body Composition AnalyzerLife Measurement, Inc.2004—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199510
FIG. 1 — Lineage of K032610, 1990–2004Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

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What was it cleared against? (2)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K924972Sonamet Body Composition Analyzer
Summary page 2
…FDA clearance: Device Name Manufacturer K Number Sonamet Body Life Measurement, K924972 Composition Analyzer Inc. EM- SCAN HP-2 EM-SCAN, Inc. K902042…
Life Measurement Instruments, Inc.1995—
*K902042EM-Scan HP-2 Pediatric Body Composition Analyzer
Summary page 2
…Life Measurement, K924972 Composition Analyzer Inc. EM- SCAN HP-2 EM-SCAN, Inc. K902042 Pediatric Body Composition Analyzer The intended use and technological characteristics of the modified S…
Em-Scan, Inc.1990—

Also cleared against K924972: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • None of the 2 ancestors has a recall.
  • 1 other device also cites its predicate K924972.

How does its category compare?

All OAC devices

OAC Plethysmograph, Air Displacement For Body Composition Analysis: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · OAC

FDA has decided no OAC device since 2007.

Median 510(k) review, days · OAC

Too few OAC 510(k)s in any year since 2007 to give a median.

Recalls per year · OAC

No recall names OAC since 2007.

Adverse event reports per year · OAC

No MAUDE report names OAC since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

What is it indicated for?

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.

Indications for use as stated in the FDA summary.

Also cleared against K924972

1 other device cites the same predicate.

  • K060848Bod PodLife Measurement, Inc. · 2006

More from Life Measurement, Inc.

2 FDA decisions under this applicant name. See the company

  • K060848Bod PodLife Measurement, Inc. · 2006

Recent decisions in OAC

The OAC category page

  • K060848Bod PodLife Measurement, Inc. · 2006
  • K924972Sonamet Body Composition AnalyzerLife Measurement Instruments, Inc. · 1995

https://510kreport.com/device/K032610 · printed Nov 4, 2026

Cite this page

510(k) Report. “K032610: Modified Sonamet Body Composition Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K032610

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026