# K011797: Bioztect Sensor and Bioztect Cable

- Pathway: 510(k) (Special)
- Applicant: Cardiodynamics International Corp.
- Decided: Jul 3, 2001 after 25 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 K001100 (2000). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001100: Bioz.Com Hemodynamic Monitor with Bioz Tect Sensor and Bioz Tect Cable Impedance Plethysmograph, Cardiodynamics International Corp. (2000) Summary page 1.

## Indications for use
The BioZtect Sensor and BioZtect Cable are used with the GE Medical Systems Solar ICG (Impedance Cardiography) Module (K010164) and are intended to monitor and display a patient’s hemodynamic parameters. The following are parameters that are available, to be used as needed by the ICG Module: Acceleration Index, Cardiac Output, Cardiac Index, ECG, End Diastolic Volume, End Diastolic Index, Heart Rate, Index of Contractility, Indexed Systemic Vascular Resistance, Left Cardiac Work, Indexed Left Cardiac Work, Left Ventricular Ejection Time, Pre-Ejection Period, Stroke Volume, Stroke Index, Systolic Time Ratio, Systemic Vascular Resistance, Thoracic Fluid Content, Respiration Rate, Velocity Index

Source page: https://510kreport.com/device/K011797
Methodology: https://510kreport.com/methodology