# K042113: Zoe Fluid Status Monitor

- Pathway: 510(k) (Special)
- Applicant: Noninvasive Medical Technologies, LLC
- Decided: Sep 14, 2004 after 40 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: 1 generation back to K922218 (1992). 2 ancestors in all.
76 later devices descend from it; 5 cite it directly.
0 of 79 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K922218: IQ System, Renaissance Technology, Inc. (1992) Summary page 1.
- K981720: IQ System, Renaissance Technology, Inc. (1999) Summary page 1.

## Most influential descendants
- K083287: Avivo Mobile Patient Management System (2009), 57 descendants of its own
- K090696: Nuvant Cardiac Event Monitoring System; Nuvant Mobile Cardiac Telemetry System (2009), 40 descendants of its own
- K091971: Avivo Mobile Patient Management System, Nuvant Mobile Cardiac Telemetry (MCT) System (2009), 38 descendants of its own
- K111917: Nuvant, Mobile Cardiac Telemetry (2011), 30 descendants of its own
- K113372: Nuvant, Mobilc Cardiac Telemetry (2012), 24 descendants of its own

## Indications for use
As with the predicate devices indicated in this submission (cardiac monitors employing impedance plethysmography {DSB}): The ZOETM Fluid Status Monitor is intended for: 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 The ZOETM Fluid Status Monitor is contraindicated for use with patients: With allergies to electrode hydrogel Skin sensitivities to electrode hydrogel Skin breakdown in areas on the chest where ZOE electrode placement is required. This device is intended for use by qualified health care practitioners, 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/K042113
Methodology: https://510kreport.com/methodology