# K974725: Bioz.Com System

- Pathway: 510(k) (Traditional)
- Applicant: Cardiodynamics International Corp.
- Decided: Mar 18, 1998 after 90 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 K972320 (1997). 1 ancestor in all.
19 later devices descend from it; 3 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972320: Bioz System & Bioz Portable, Cardiodynamics International Corp. (1997) Summary page 1.

## Most influential descendants
- K041434: C3 and Lifegard Icg Impedance Cardiography Monitors (2004), 11 descendants of its own
- K041294: Biozdx Hemodynamic Monitor (2004), 9 descendants of its own
- K051228: Biozdx Hemodynamic Monitor and 12-Lead Ecg (2005), 5 descendants of its own
- K060387: Physioflow System (2008), 4 descendants of its own
- K070156: Bioz DX Hemodynamic Monitor with Philips 12-Lead Ecg, Model 5100 (2007), 4 descendants of its own

## Indications for use
The BioZ.com Hemodynamic Monitor is intended to monitor a patient’s hemodynamic parameters. These parameters include: ECG Heart Rate Pre-ejection Period Left Ventricular Ejection Time Systolic Time Ratio Stroke Volume Cardiac Output Cardiac Index Systemic Vascular Resistance End Diastolic Volume End Diastolic Index Index of Contractility Acceleration Index Left Cardiac Work Thoracic Fluid Content Respiration Rate

Source page: https://510kreport.com/device/K974725
Methodology: https://510kreport.com/methodology