# K172507: SOZO

- Pathway: 510(k) (Traditional)
- Applicant: ImpediMed Limited
- Decided: Dec 22, 2017 after 126 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: 6 generations back to K922218 (1992). 7 ancestors in all.
7 later devices descend from it; 2 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142503: Imed-Z Fluid Status Monitor, Intersection Medical, Inc. (2015) Summary page 4.

## Most influential descendants
- K193410: SOZO Body Fluid Analyzer (2020), 4 descendants of its own
- K203473: SOZO (2021), 3 descendants of its own
- K232089: SOZO Pro (2023), 2 descendants of its own
- K190529: SOZO (2019), 1 descendant of its own
- K260224: MySOZO Software version 6.1.0.1 (SW version 6.1.0.1) (2026), 0 descendants of its own

## Indications for use
The SOZO Fluid Status Monitor 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/K172507
Methodology: https://510kreport.com/methodology