# K082255: Quadscan 4000 Body Body Composition, Fluid & Illness/Segmental Monitoring Unit

- Pathway: 510(k) (Traditional)
- Applicant: Bodystat, Ltd.
- Decided: Feb 7, 2011 after 913 days
- Product code: MNW (Analyzer, Body Composition)
- Device class: 2
- Regulation: 21 CFR 870.2770
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K002835 (2001). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002835: Bodystat, Bodystat, Ltd. (2001) Summary page 1.

## Indications for use
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.

Source page: https://510kreport.com/device/K082255
Methodology: https://510kreport.com/methodology