# K172122: SOZO

- Pathway: 510(k) (Special)
- Applicant: ImpediMed Limited
- Decided: Aug 11, 2017 after 29 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: 5 generations back to K904109 (1991). 7 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130338: Impedimed - Bis Extra Cellular Fluid Analysis, ImpediMed Limited (2013) Summary page 4.

## Most influential descendants
- K180126: SOZO (2018), 1 descendant of its own
- K230530: SOZO Pro (2023), 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. SOZOhub PC software — a PC software package that is intended to be used only with the ImpediMed SOZO device for uploading data on to the PC from the SOZO device, processing and analyzing of bioimpedance measurements.

Source page: https://510kreport.com/device/K172122
Methodology: https://510kreport.com/methodology