# K080825: Impedimed Extra Cellular Fluid Analysis, Model L-Dex U400

- Pathway: 510(k) (Traditional)
- Applicant: Impedimed Pty, Ltd.
- Decided: Oct 3, 2008 after 193 days
- Product code: OBH (Monitor, Extracellular Fluid, Lymphedema, Extremity)
- 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: 2 generations back to K904109 (1991). 4 ancestors in all.
10 later devices descend from it; 2 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050415: Impedimed-Extracellular Fluid Analysis, Impedimed Pty, Ltd. (2007) Summary page 2.
- K052319: Impedimed - Body Composition Analyzer, Model Imp SFB7, Impedimed Pty, Ltd. (2006) Summary page 2.

## Most influential descendants
- K100811: Impedimed - Extracellular Fluid Analyzer Model: L-Dex U400 (2011), 7 descendants of its own
- K130338: Impedimed - Bis Extra Cellular Fluid Analysis (2013), 6 descendants of its own
- K171186: Cerebrotech CMS-5000 (2017), 2 descendants of its own
- K172122: SOZO (2017), 2 descendants of its own
- K182967: Visor System (2018), 1 descendant of its own

## Indications for use
The L-Dex U400: A bioelectrical impedance analyzer/monitor utilizing impedance ratios that supports the measurement of extra cellular fluid volume differences between the arms to aid in the clinical assessment of unilateral lymphedema of the arm in women. This device is not intended to diagnose or predict lymphedema of an extremity. Lymphedema Analysis PC Software - an optional PC software package that is intended to be used only with the ImpediMed L-Dex U400 analyzer/monitor for uploading data on to the PC from the L-Dex U400, processing and analyzing of bioimpedance measurements.

Source page: https://510kreport.com/device/K080825
Methodology: https://510kreport.com/methodology