# K050415: Impedimed-Extracellular Fluid Analysis

- Pathway: 510(k) (Traditional)
- Applicant: Impedimed Pty, Ltd.
- Decided: Mar 30, 2007 after 770 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: 1 generation back to K904109 (1991). 2 ancestors in all.
11 later devices descend from it; 1 cites it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K904109: Bio-Impedance Analyzer, Xitron Technologies, Inc. (1991) Summary page 2.
- K002835: Bodystat, Bodystat, Ltd. (2001) Summary page 2.

## Most influential descendants
- K080825: Impedimed Extra Cellular Fluid Analysis, Model L-Dex U400 (2008), 10 descendants of its own
- 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

## Indications for use
Imp XCA - 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 lymphoedema of the arm. This device is not intended to diagnose or predict lymphoedema of an extremity. Lymphoedema Analysis PC Software — an optional PC software package that is intended to be used only with the ImpediMed Imp XCA analyzer/monitor for uploading the data on to the PC from the Imp XCA via an infrared transfer for storing, processing and analyzing of bioimpedance measurements.

Source page: https://510kreport.com/device/K050415
Methodology: https://510kreport.com/methodology