510(k) · Cleared
ClearedModification to Bodystat 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 Feb 7, 2011 as substantially equivalent to K994242 (Bodystat, Ltd., 2000) and 1 other predicate after a 913-day review. Its family tree reaches back 1 generation to 2000.
- Decided
- Feb 7, 2011
- Review
- 913 days
- Class
- Class II
- Product code
- MNW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K994242 (2000). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK994242 Bodystat 1500MDD Body Composition Monitoring UnitBodystat, Ltd. · 2000
- This deviceK082254 Modification to Bodystat 1500MDD Body Composition Monitoring UnitBodystat, Ltd. · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K994242 | Bodystat 1500MDD Body Composition Monitoring Unit | Bodystat, Ltd. | 2000 | — |
| 0 (this device) | K082254 | Modification to Bodystat 1500MDD Body Composition Monitoring Unit | Bodystat, Ltd. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 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 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? (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 |
|---|---|---|---|
| * | K994242 | Bodystat 1500MDD Body Composition Monitoring UnitSummary page 1…The BODYSTAT®1I 500MDD Body Composition Monitoring Unit is substantially equivalent to the following previously cleared and legally marketed devices: * K994242, Bodystat I1500NMD Body Composition Monitoring Unit. * K002835, Bodystat Quadscan Quad Frequency Monitoring Unit DI.… | 2000 |
| * | K002835 | BodystatSummary page 1…equivalent to the following previously cleared and legally marketed devices: * K994242, Bodystat I1500NMD Body Composition Monitoring Unit. * K002835, Bodystat Quadscan Quad Frequency Monitoring Unit DI. Device Description: The Bodystat I1500MDD Body Composition Monito… | 2001 |
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 K994242.
How does its category compare?
All MNW devicesMNW Analyzer, Body Composition: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
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?
For the purposes of performing a non-invasive BIA measurement on normal healthy human adults and children to determine their Body Composition status. The measurements include Body Mass Index (BMI), waist/hip ratio, tissue impedance at 5kHz and at 50kHz. These measurements are used to calculate the estimated levels of body fat, body lean and dry lean, total body water, and metabolic rates. Bodystat BODY MANAGER and WELLNESS SOFTWARE PROGRAMS are…
Read the full statement (129 words)
For the purposes of performing a non-invasive BIA measurement on normal healthy human adults and children to determine their Body Composition status.
The measurements include Body Mass Index (BMI), waist/hip ratio, tissue impedance at 5kHz and at 50kHz. These measurements are used to calculate the estimated levels of body fat, body lean and dry lean, total body water, and metabolic rates.
Bodystat BODY MANAGER and WELLNESS SOFTWARE PROGRAMS are automatically included with this device.
The Body Manager Program is designed for when a client returns to be tested in order to track their changes in body composition over a period of time.
The Weliness Program is designed for first time assessments on subjects. The program's graphical presentations provide information on each of the specific measurements in an educational format.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082254 · printed Nov 5, 2026
Cite this page
510(k) Report. “K082254: Modification to Bodystat 1500MDD Body Composition Monitoring Unit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K082254
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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