# K250922: Edema Guard Monitor (EGM) CardioSet-001

- Pathway: 510(k) (Traditional)
- Applicant: Cardioset Medical, Ltd.
- Decided: Sep 9, 2025 after 166 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.
No later device cites it as a predicate yet.
0 of 7 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 5.

## Indications for use
The EGM CardioSet-001 is intended for patients with any of the following conditions: ● With fluid management problems ● Taking diuretic medication ● Living with heart failure ● Suffering or recovering from a coronary artery disease-related event 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 both the inpatient and outpatient setting. The EGM CardioSet-001 reading is intended to be used as an adjunct parameter to standard clinical assessment methods and should not be the sole input used to guide treatment.

Source page: https://510kreport.com/device/K250922
Methodology: https://510kreport.com/methodology