510(k) · Cleared
ClearedQuadscan 4000 Body Body Composition, Fluid & Illness/Segmental 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 K002835 (Bodystat, Ltd., 2001) after a 913-day review. Its family tree reaches back 1 generation to 2001.
- Decided
- Feb 7, 2011
- Review
- 913 days
- Class
- Class II
- Product code
- MNW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K002835 (2001). No later device cites it as a predicate yet.
- Root · 1 generation backK002835 BodystatBodystat, Ltd. · 2001
- This deviceK082255 Quadscan 4000 Body Body Composition, Fluid & Illness/Segmental…Bodystat, Ltd. · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K002835 | Bodystat | Bodystat, Ltd. | 2001 | — |
| 0 (this device) | K082255 | Quadscan 4000 Body Body Composition, Fluid & Illness/Segmental Monitoring Unit | Bodystat, Ltd. | 2011 | — |
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? (1)
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 |
|---|---|---|---|
| * | K002835 | BodystatSummary page 1…uid Monitoring Unit is substantially equivalent to the QuadScan Quad Frequency Monitoring Unit & QuadScan Wellness and Hydration Software Program cleared under K002835. D. Device Description: The QuadScan 4000 Body Composition & Fluid Monitoring Unit is a light weight, handheld, bat… | 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?
- Its one ancestor has no recall.
- 7 other devices also cite its predicate K002835.
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 non-invasive bio-eleetrical impedance analysis (BIA) measurements on healthy human adults and children to determine their Body Composition & Hydration status.
The measurements include Body Mass Index (BMI), waist/hip ratio, tissue impedance at 5, 50, 100, and 200 kHz. These measurements are used to calculate the estimated levels of extra-cellular water, intracellular water, total body water, body fat, body lean and dry lean, metabolic rates.
QuadScan 4000 for Windows Software Program is automatically included with the device.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082255 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082255: Quadscan 4000 Body Body Composition, Fluid & Illness/Segmental Monitoring Unit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082255
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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