# K131509: Zoe Fluid Status Monitor

- Pathway: 510(k) (Special)
- Applicant: Noninvasive Medical Technologies, Inc.
- Decided: Jun 28, 2013 after 35 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: 3 generations back to K922218 (1992). 4 ancestors in all.
18 later devices descend from it; 2 cite it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112830: Zoefluid Status Monitor (Model Zoe 2B), Noninvasive Medical Technologies, Inc. (2012) Summary page 1.

## Most influential descendants
- K133301: Zoe Fluid Status Monitor (2014), 17 descendants of its own
- K142503: Imed-Z Fluid Status Monitor (2015), 10 descendants of its own
- 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

## Indications for use
The ZOE 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/K131509
Methodology: https://510kreport.com/methodology