# K191697: Cardiac Monitor 1500

- Pathway: 510(k) (Traditional)
- Applicant: Zynex Medical, Inc.
- Decided: Feb 21, 2020 after 241 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: 2 generations back to K972320 (1997). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974725: Bioz.Com System, Cardiodynamics International Corp. (1998) Summary page 5.
- K102350: Pulse Oximeter, Nonin Medical, Inc. (2010) Summary page 5.
- K011291: Temporalscanner Thermometer, Sensortouch, Exergen Corp. (2001) Summary page 5.

## Most influential descendants
- K223217: Zynex Monitoring System, Model CM-1600 (2023), 0 descendants of its own

## Indications for use
Monitoring of the following parameters and their relative changes, indicative of relative changes in fluid volume in adult patients. • Bioelectrical Impedance • Heart Rate • ECG Amplitude • PPG Amplitude

Source page: https://510kreport.com/device/K191697
Methodology: https://510kreport.com/methodology