# K130338: Impedimed - Bis Extra Cellular Fluid Analysis

- Pathway: 510(k) (Traditional)
- Applicant: ImpediMed Limited
- Decided: May 31, 2013 after 109 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: 4 generations back to K904109 (1991). 6 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100811: Impedimed - Extracellular Fluid Analyzer Model: L-Dex U400, ImpediMed Limited (2011) Summary page 1.

## Most influential descendants
- 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
- K180126: SOZO (2018), 1 descendant of its own
- K253840: STEDI Scan Device (2026), 0 descendants of its own

## Indications for use
A bioimpedance spectroscopy device for use on adult human patients, utilizing impedance ratios that are displayed as an L-Dex ratio that supports the measurement of extracellular fluid volume differences between the limbs and is presented to the clinician on an L-Dex scale as an aid to their clinical assessment of unilateral lymphedema of the arm and leg in women and the leg in men. The device is only indicated for patients who will have or who have had lymph nodes, from the axillary and pelvic regions, either removed, damaged or irradiated. Lymphedema Analysis PC Software - an optional PC software package that is intended to be used only with the ImpediMed L-Dex U400 device for uploading data on to the PC from the L-Dex U400, processing and analyzing of bioimpedance measurements.

Source page: https://510kreport.com/device/K130338
Methodology: https://510kreport.com/methodology