# K082147: Bodymetrix BX2000

- Pathway: 510(k) (Traditional)
- Applicant: Intelametrix, Inc.
- Decided: Mar 20, 2009 after 233 days
- Product code: OMV (Ultrasonic Body Composition Analyzer)
- 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: 5 generations back to K894632 (1989). 18 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K810116: Isorobic Skinfold Caliper, Fitness Motivation Institute of America (1981) Summary page 1.
- K051334: Terason Ultrasound System with Continuous Wave Soppler, Teratech Corp. (2005) Summary page 1.

## Most influential descendants
- K202514: EchoS Family (2021), 1 descendant of its own
- K212851: EchoSK and EchoSGyn modules for EchoS Family devices (2022), 0 descendants of its own

## Indications for use
(1) BodyMetrix BX2000 is indicated for the measurement of localized fat layer thickness and localized muscle thickness. When used with the BodyView Software it can be used to estimate total body fat percentage (%BF). The BX2000 is only intended to be used on generally healthy adults and children (6 or older) and is not for diagnosis of disease or condition. (2) The BodyView Software is indicated for the calculation of the estimated total body fat percentage (%BF), localized fat layer thickness, and localized muscle thickness. The BodyView Software is indicated for calculating Waist-to-Hip Ratio (WHR), and Body Mass Index (BMI). The BodyView Software is indicated for estimating Basal Metabolic Rate (BMR). The BodyView software can track changes in the measurements,' and generate body composition reports.

Source page: https://510kreport.com/device/K082147
Methodology: https://510kreport.com/methodology