510(k) · Cleared
ClearedBodystat
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bodystat, Ltd. · MNW Analyzer, Body Composition
Cleared on Jul 3, 2001 after a 294-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 34 later devices descend from it.
- Decided
- Jul 3, 2001
- Review
- 294 days
- Class
- Class II
- Product code
- MNW
- Recalls
- None
- Predicates
- 0
34 later devices descend from it, 8 citing it directly.
- This deviceK002835 BodystatBodystat, Ltd. · 2001
- Descendant · cites it directly · 11 of its ownK050415 Impedimed-Extracellular Fluid AnalysisImpedimed Pty, Ltd. · 2007
- Descendant · cites it directly · 11 of its ownK023478 Inbody AP1 Body Composition AnalyzerBiospace Co.,Ltd · 2003
- Descendant · 2 generations on · 10 of its ownK080825 Impedimed Extra Cellular Fluid Analysis, Model L-Dex U400Impedimed Pty, Ltd. · 2008
- Descendant · cites it directly · 10 of its ownK042528 Inbody, Model 3.0Biospace Corporation Limited · 2005
- Descendant · 2 generations on · 8 of its ownK052646 Biospace Body Composition Analyzers, Models Inbody 520, 720 and S20Biospace Corporation Limited · 2005
Showing 5 of 34 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 34 · See all- K050415Impedimed-Extracellular Fluid AnalysisImpedimed Pty, Ltd. · 2007 · cites it directly11descendants
- K023478Inbody AP1 Body Composition AnalyzerBiospace Co.,Ltd · 2003 · cites it directly11descendants
- K080825Impedimed Extra Cellular Fluid Analysis, Model L-Dex U400Impedimed Pty, Ltd. · 2008 · 2 generations on10descendants
- K042528Inbody, Model 3.0Biospace Corporation Limited · 2005 · cites it directly10descendants
- K052646Biospace Body Composition Analyzers, Models Inbody 520, 720 and S20Biospace Corporation Limited · 2005 · 2 generations on8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K002835 | Bodystat | Bodystat, Ltd. | 2001 | — |
| +1 | K050415 | Impedimed-Extracellular Fluid Analysis | Impedimed Pty, Ltd. | 2007 | — |
| +1 | K023478 | Inbody AP1 Body Composition Analyzer | Biospace Co.,Ltd | 2003 | — |
| +2 | K080825 | Impedimed Extra Cellular Fluid Analysis, Model L-Dex U400 | Impedimed Pty, Ltd. | 2008 | — |
| +1 | K042528 | Inbody, Model 3.0 | Biospace Corporation Limited | 2005 | — |
| +2 | K052646 | Biospace Body Composition Analyzers, Models Inbody 520, 720 and S20 | Biospace Corporation Limited | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 5 | 0 |
| 2008 | 3 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 6 | 0 |
| 2013 | 4 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MNW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MNW device
- #1 K231116 Multi-parameter detectorscore 11.4 · 14 generations · no Class I recall
What was it cleared against?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (34)
See all 348 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K050415 | Impedimed-Extracellular Fluid Analysis | 2007 | 11 |
| K023478 | Inbody AP1 Body Composition Analyzer | 2003 | 11 |
| K042528 | Inbody, Model 3.0 | 2005 | 10 |
| K053556 | Body Composition Analyzer, Models Zeus 9.9 and Venus 5.5 | 2006 | 4 |
| K070999 | BC (Body Composition Software) | 2007 | 1 |
| K082254 | Modification to Bodystat 1500MDD Body Composition Monitoring Unit | 2011 | 0 |
| K082255 | Quadscan 4000 Body Body Composition, Fluid & Illness/Segmental Monitoring Unit | 2011 | 0 |
| K073334 | Ohmniscan NG | 2008 | 0 |
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?
- Of its descendants, K050415 (Impedimed Pty, Ltd., 2007) has gone furthest, with 11 descendants of its own.
How does its category compare?
All MNW devicesMNW Analyzer, Body Composition: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MNW
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · MNW
110in 2014
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MNW
No recall names MNW since 2007.
Adverse event reports per year · MNW
3in 2024
MAUDE reports naming product code MNW, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 4 | 109 | 0 | 0 |
| 2008 | 4 | 134 | 0 | 0 |
| 2009 | 4 | 137 | 0 | 0 |
| 2010 | 1 | — | 0 | 1 |
| 2011 | 11 | 168 | 0 | 0 |
| 2012 | 4 | 103 | 0 | 0 |
| 2013 | 9 | 144 | 0 | 0 |
| 2014 | 3 | 110 | 0 | 0 |
| 2015 | 1 | — | 0 | 2 |
| 2016 | 0 | — | 0 | 15 |
| 2017 | 0 | — | 0 | 6 |
| 2018 | 0 | — | 0 | 16 |
| 2019 | 0 | — | 0 | 11 |
| 2020 | 0 | — | 0 | 12 |
| 2021 | 0 | — | 0 | 10 |
| 2022 | 0 | — | 0 | 8 |
| 2023 | 0 | — | 0 | 2 |
| 2024 | 1 | — | 0 | 3 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K002835 · printed Nov 4, 2026
Cite this page
510(k) Report. “K002835: Bodystat.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K002835
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026