# K041294: Biozdx Hemodynamic Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Cardiodynamics International Corp.
- Decided: Dec 8, 2004 after 208 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). 3 ancestors in all.
9 later devices descend from it; 3 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001081: Bioz.PC Hemodynamic Monitor Model BZ-500/BZ-501; Bioz.PC User Software Installation Kit Model BZ-810, Cardiodynamics International Corp. (2000) Summary page 1.
- K974725: Bioz.Com System, Cardiodynamics International Corp. (1998) Summary page 1.

## Most influential descendants
- K051228: Biozdx Hemodynamic Monitor and 12-Lead Ecg (2005), 5 descendants of its own
- K070156: Bioz DX Hemodynamic Monitor with Philips 12-Lead Ecg, Model 5100 (2007), 4 descendants of its own
- K073280: Beneview T Series Patient Monitors, Models T8, T6 and T5 (2008), 2 descendants of its own
- K110922: Patient Monitor (2011), 1 descendant of its own
- K090602: Cardiodynamics Bioz RX, Model 7101-Sys (2009), 1 descendant of its own

## Indications for use
The BioZDx Hemodynamic Monitor is intended to monitor and display a patient's hemodynamic parameters. These parameters include: ECG Pre-Ejection Period Systolic Time Ratio Cardiac Output Heart Rate End diastolic Index Thoracic Fluid Content Acceleration Index Cardiac Index Left Vent. Ejection Time Index of Contractility End Diastolic Volume Mean Blood Pressure Stroke Volume Systemic Vascular Resistance Systolic Blood PressureLeft Cardiac Work Diastolic Blood Pressure

Source page: https://510kreport.com/device/K041294
Methodology: https://510kreport.com/methodology