# K972320: Bioz System & Bioz Portable

- Pathway: 510(k) (Traditional)
- Applicant: Cardiodynamics International Corp.
- Decided: Sep 11, 1997 after 80 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
No predicates in its family tree.
20 later devices descend from it; 1 cites 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)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K974725: Bioz.Com System (1998), 19 descendants of its own
- 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

## Indications for use
The BioZ System was designed to monitor a patients hemodynamic parameters. These include ECG, HR, PEP, LVET, STR, SV, S1, CO, CI, SVR. SVRI, EDV, EDI, IC, ACI, LCW and TFC.

Source page: https://510kreport.com/device/K972320
Methodology: https://510kreport.com/methodology