510(k) · Cleared
ClearedBodystat 1500MDD Body Composition Monitoring Unit
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 Mar 15, 2000 after a 90-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 4 later devices descend from it.
- Decided
- Mar 15, 2000
- Review
- 90 days
- Class
- Class II
- Product code
- MNW
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK994242 Bodystat 1500MDD Body Composition Monitoring UnitBodystat, Ltd. · 2000
- Descendant · cites it directly · 2 of its ownK050395 Impedimed - Body Composition AnalysisImpedimed Pty, Ltd. · 2005
- Descendant · 2 generations on · 1 of its ownK070999 BC (Body Composition Software)Rjl Systems, Inc. · 2007
- Descendant · 2 generations on · 0 of its ownK103026 Electro Sensor -Body CompositionLd Technology, LLC · 2011
- Descendant · cites it directly · 0 of its ownK082254 Modification to Bodystat 1500MDD Body Composition Monitoring UnitBodystat, Ltd. · 2011
Most influential descendants
Showing 4 of 4 · See all- K050395Impedimed - Body Composition AnalysisImpedimed Pty, Ltd. · 2005 · cites it directly2descendants
- K070999BC (Body Composition Software)Rjl Systems, Inc. · 2007 · 2 generations on1descendant
- K103026Electro Sensor -Body CompositionLd Technology, LLC · 2011 · 2 generations on0descendants
- K082254Modification to Bodystat 1500MDD Body Composition Monitoring UnitBodystat, Ltd. · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K994242 | Bodystat 1500MDD Body Composition Monitoring Unit | Bodystat, Ltd. | 2000 | — |
| +1 | K050395 | Impedimed - Body Composition Analysis | Impedimed Pty, Ltd. | 2005 | — |
| +2 | K070999 | BC (Body Composition Software) | Rjl Systems, Inc. | 2007 | — |
| +2 | K103026 | Electro Sensor -Body Composition | Ld Technology, LLC | 2011 | — |
| +1 | K082254 | Modification to Bodystat 1500MDD Body Composition Monitoring Unit | Bodystat, Ltd. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2011 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), 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’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K050395 (Impedimed Pty, Ltd., 2005) has gone furthest, with 2 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 | — |
What is it indicated for?
Teaturerenr oF:
Lirinaten: Rory Far
8ory Lean + Doy Léean
Torar bopy WaTER
Heragonrc KaATEL
Aerunt: Boyy Mage Trdex (4AHT)
Waer /H/P Fano
THPedance atr SowHaz
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K994242 · printed Nov 4, 2026
Cite this page
510(k) Report. “K994242: Bodystat 1500MDD Body Composition Monitoring Unit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K994242
Report an extraction error
Are you the manufacturer?
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