510(k) · Cleared
ClearedBodymetrix BX2000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Intelametrix, Inc. · OMV Ultrasonic Body Composition Analyzer
Cleared on Mar 20, 2009 as substantially equivalent to K810116 (Fitness Motivation Institute of America, 1981) and 1 other predicate after a 233-day review. Its family tree reaches back 5 generations to 1989. 2 later devices descend from it.
- Decided
- Mar 20, 2009
- Review
- 233 days
- Class
- Class II
- Product code
- OMV
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K894632 (1989). 18 ancestors in all, the oldest K810116 (1981). 2 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK894632 Model SSH-140A Ultrasound Imaging SystemToshiba America Medical Systems, In.C · 1989
- 4 generations backK941593 Diagnostic Ultrasonic TransducerToshiba America Medical Systems, In.C · 1996
- 3 generations backK970047 Phased Array Transducer - - PSK-20CTToshiba America Medical Systems, In.C · 1997
- 2 generations backK991710 Ssa-370A/Powervision 6000Toshiba America Medical Systems, In.C · 1999
- 1 generation backK051334 Terason Ultrasound System with Continuous Wave SopplerTeratech Corp. · 2005
- This deviceK082147 Bodymetrix BX2000Intelametrix, Inc. · 2009
- Descendant · cites it directly · 1 of its ownK202514 EchoS FamilyEcholight S.P.A · 2021
- Descendant · 2 generations on · 0 of its ownK212851 EchoSK and EchoSGyn modules for EchoS Family devicesEcholight S.P.A · 2022
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K894632 | Model SSH-140A Ultrasound Imaging System | Toshiba America Medical Systems, In.C | 1989 | — |
| −4 | K941593 | Diagnostic Ultrasonic Transducer | Toshiba America Medical Systems, In.C | 1996 | — |
| −3 | K970047 | Phased Array Transducer - - PSK-20CT | Toshiba America Medical Systems, In.C | 1997 | — |
| −2 | K991710 | Ssa-370A/Powervision 6000 | Toshiba America Medical Systems, In.C | 1999 | — |
| −1 | K051334 | Terason Ultrasound System with Continuous Wave Soppler | Teratech Corp. | 2005 | — |
| 0 (this device) | K082147 | Bodymetrix BX2000 | Intelametrix, Inc. | 2009 | — |
| +1 | K202514 | EchoS Family | Echolight S.P.A | 2021 | — |
| +2 | K212851 | EchoSK and EchoSGyn modules for EchoS Family devices | Echolight S.P.A | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1989 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 4 | 0 |
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
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.
Planning a device in OMV? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K810116 | Isorobic Skinfold CaliperSummary page 1…II - Analyzer, Body Composition, Ultrasonic (21 CFR 870.2770) Predicate Devices: K810116 Isorobic Skinfold Caliper Teratech Corpo… | 1981 |
| * | K051334 | Terason Ultrasound System with Continuous Wave SopplerSummary page 1…Teratech Corporation TERASON T2000 Ultrasound System K051334 Description of the Device: BodyMetrix BX2000TM is a portable, hand-held device that uses A-mode ultrasound to measure tissue th… | 2005 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K202514 | EchoS Family | 2021 | 1 |
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?
- The line of descent spans 20 years and passes through 3 companies; a new generation was cleared every 3.8 years on median.
- None of the 18 ancestors has a recall.
- Of its descendants, K202514 (Echolight S.P.A, 2021) has gone furthest, with 1 descendant of its own.
How does its category compare?
All OMV devicesOMV Ultrasonic Body Composition Analyzer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · OMV
1in 2009
2026 to Oct 25, outlined.
Median 510(k) review, days · OMV
Too few OMV 510(k)s in any year since 2007 to give a median.
Recalls per year · OMV
No recall names OMV since 2007.
Adverse event reports per year · OMV
No MAUDE report names OMV since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
(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…
Read the full statement (125 words)
(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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082147 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082147: Bodymetrix BX2000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082147
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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