# K223217: Zynex Monitoring System, Model CM-1600

- Pathway: 510(k) (Traditional)
- Applicant: Zynex Medical, Inc.
- Decided: Jun 16, 2023 after 242 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 K972320 (1997). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191697: Cardiac Monitor 1500, Zynex Medical, Inc. (2020) Summary page 5.

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

Source page: https://510kreport.com/device/K223217
Methodology: https://510kreport.com/methodology