# K142503: Imed-Z Fluid Status Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Intersection Medical, Inc.
- Decided: Jun 5, 2015 after 273 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: 5 generations back to K922218 (1992). 6 ancestors in all.
10 later devices descend from it; 3 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133301: Zoe Fluid Status Monitor, Noninvasive Medical Technologies, Inc. (2014) Summary page 4.

## Most influential descendants
- K172507: SOZO (2017), 7 descendants of its own
- 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

## Indications for use
The IMED-Z Fluid Status Monitor is intended for patients: With fluid management problems Taking diuretic medication Living with Heart Failure Living with End-stage Renal Disease Recovering from Coronary artery Disease related event Suffering from Recurrent Dehydration This device is intended for use, under the direction of a physician, for the non-invasive monitoring and management of patients with fluid management problems in a variety of medically accepted clinical applications.

Source page: https://510kreport.com/device/K142503
Methodology: https://510kreport.com/methodology