# K090602: Cardiodynamics Bioz RX, Model 7101-Sys

- Pathway: 510(k) (Traditional)
- Applicant: Cardiodynamics International Corp.
- Decided: May 28, 2009 after 84 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: 5 generations back to K895520 (1990). 18 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070156: Bioz DX Hemodynamic Monitor with Philips 12-Lead Ecg, Model 5100, Cardiodynamics International Corp. (2007) Summary page 1.
- K051228: Biozdx Hemodynamic Monitor and 12-Lead Ecg, Cardiodynamics International Corp. (2005) Summary page 1.
- K052158: Welch Allyn Cardioperfect Workstation Version 1.5.0 Software, Welch Allyn, Inc. (2005) Summary page 1.
- K962854: Hardware:Cardio Perfect Portable, Cardio Perfect MD and Software:Cardio Perfect (V. 4.0 and UP for Dos), Cardio Perfect, Cardio Control BV (1997) Summary page 1.

## Most influential descendants
- K110645: Bio Z Cardio Profile Hemodynamic Monitor (2011), 0 descendants of its own

## Indications for use
For the ICG function: The BioZ Rx Hemodynamic Monitor is intended to monitor and display a patient's hemodynamic parameters. These parameters include: Heart Rate (HR) Thoracic Fluid Content Index (TFCI) Systolic Blood Pressure (SBP) Systolic Time Ratio (STR) Diastolic Blood Pressure (DBP) Systolic Time Ratio Index (STRI) Mean Arterial Blood Pressure (MAP) Pre-Ejection Period (PEP) Stroke Index (SI) Left Ventricular Ejection Time (LVET) Stroke Volume (SV) Total Arterial Compliance (TAC) Cardiac Index (CI) Total Arterial Compliance Index (TACI) Cardiac Output (CO) Left Stroke Work Index (LSWI) Systemic Vascular Resistance (SVR) Heather Index (RI) Systemic Vascular Resistance Index (SVRI) Q-C Interval (QC) Left Cardiac Work (LCW) Left Cardiac Work Index (LCWI) Acceleration Index (ACI) Systemic Stroke Resistance Index (SSRI/SSVRI) Velocity Index/Index of Contractility (VI, IC) Base Impedance (TFf or Z4) Thoracic Fluid Content (TFC) Electrocardiogram (ECG) For the optional 12-lead ECG function: Where the clinician decides to evaluate the electrocardiogram of adult and pediatric patients as part of decisions regarding possible diagnosis, potential treatment, effectiveness of treatment or to rule-out causes for symptoms.

Source page: https://510kreport.com/device/K090602
Methodology: https://510kreport.com/methodology