# K070156: Bioz DX Hemodynamic Monitor with Philips 12-Lead Ecg, Model 5100

- Pathway: 510(k) (Traditional)
- Applicant: Cardiodynamics International Corp.
- Decided: Sep 26, 2007 after 252 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: 4 generations back to K895520 (1990). 13 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051228: Biozdx Hemodynamic Monitor and 12-Lead Ecg, Cardiodynamics International Corp. (2005) Summary page 1.
- K011439: Modification to Bioz.Com Hemodynamic Monitor, Cardiodynamics International Corp. (2001) Summary page 1.
- K041434: C3 and Lifegard Icg Impedance Cardiography Monitors, Analogic Corp. (2004) Summary page 1.
- K010164: Icg Module, General Electric Medical Systems Information Techn (2001) Summary page 1.

## Most influential descendants
- K090602: Cardiodynamics Bioz RX, Model 7101-Sys (2009), 1 descendant of its own
- K160899: CoVa Monitoring System 2 (2017), 0 descendants of its own
- K110645: Bio Z Cardio Profile Hemodynamic Monitor (2011), 0 descendants of its own
- K080941: Bioimpedance Cardiac Analyzing Measuring System (2009), 0 descendants of its own

## Indications for use
For the lOG function: The BioZ Dx 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 (Cl) Total Arterial Compliance Index (TACI) Cardiac Output (CO) Left Stroke Work Index (LSWI) Systemic Vascular Resistance (SVR) Heather Index (HI) Systemic Vascular Resistance Index (SVRI) Q -C Interval (QC) Left Cardiac Work (LCW) Left Cardiac Work Index (LCWI) Acceleration Index (ACl) Electrocardiograph (ECG) Velocity Index or Index of Contractility (VI, IC) Systemic Stroke Resistance Index (SSRI or SSVRI) Thoracic Fluid Content (TFC) End Diastolic Volume (EDV) Base Impedance (TFI or Z0) End Diastolic Index (EDI) 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/K070156
Methodology: https://510kreport.com/methodology