# K180126: SOZO

- Pathway: 510(k) (Traditional)
- Applicant: ImpediMed Limited
- Decided: Apr 16, 2018 after 90 days
- Product code: OBH (Monitor, Extracellular Fluid, Lymphedema, Extremity)
- Device class: 2
- Regulation: 21 CFR 870.2770
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K904109 (1991). 8 ancestors in all.
1 later device descends 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)
- K172122: SOZO, ImpediMed Limited (2017) Summary page 4.

## Most influential descendants
- K230530: SOZO Pro (2023), 0 descendants of its own

## Recalls of this device
- Aug 17, 2023 · Class II · Z-0155-2024: Bilateral L-Dex assessment software does not have the same level of sensitivity to help detect early signs of lymphedema as the unilateral arm L-Dex assessment, which could result in under-recognition

## Indications for use
The SOZO Body Fluid Analyzer has the following uses: For adult human patients at risk of lymphedema: 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 volume differences between the limbs and is presented to the clinician on an L-Dex scale as an aid to their clinical assessment of lymphedema. The use of the device to obtain an L-Dex score is only indicated for patients who will have or who have had lymph nodes, from the axillary and/or pelvic regions, either removed, damaged or irradiated.

Source page: https://510kreport.com/device/K180126
Methodology: https://510kreport.com/methodology