# K203473: SOZO

- Pathway: 510(k) (Traditional)
- Applicant: ImpediMed Limited
- Decided: Apr 19, 2021 after 145 days
- Product code: DSB (Plethysmograph, Impedance)
- 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: 8 generations back to K922218 (1992). 9 ancestors in all.
3 later devices descend from it; 1 cites 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)
- K193410: SOZO Body Fluid Analyzer, ImpediMed Limited (2020) Summary page 4.

## Most influential descendants
- K232089: SOZO Pro (2023), 2 descendants of its own
- K260224: MySOZO Software version 6.1.0.1 (SW version 6.1.0.1) (2026), 0 descendants of its own
- K253224: MySOZO Software version 6.0.1.2 (SW version 6.0.1.2) (2026), 0 descendants of its own

## Indications for use
The SOZO Body Fluid Analyzer is intended for adult patients living with heart failure. This device is intended for use, under the direction of a physician, for the noninvasive monitoring of patients with fluid management problems suffering from heart failure. Data from the device should be considered in conjunction with other clinical data.

Source page: https://510kreport.com/device/K203473
Methodology: https://510kreport.com/methodology