# K110645: Bio Z Cardio Profile Hemodynamic Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Sonosite,Inc.
- Decided: Jun 3, 2011 after 91 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: 8 generations back to K903134 (1991). 61 ancestors in all.
No later device cites it as a predicate yet.
0 of 62 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090602: Cardiodynamics Bioz RX, Model 7101-Sys, Cardiodynamics International Corp. (2009) Summary page 1.
- K041294: Biozdx Hemodynamic Monitor, Cardiodynamics International Corp. (2004) Summary page 1.
- K080670: Modification to Sphygmocor Cardiovascular Management System, Atcor Medical (2008) Summary page 1.
- K103166: Cheetah Reliant, Cheetah Medical, Inc. (2011) Summary page 1.

## Indications for use
For the LOG function: The Bio Z Cardia Profile Hemodynamic Monitor is intended to monitor and display a patient's hemodynamic parameters including; Heart Rate (HR) Velocity Index (VI) Systolic Blood Pressure (SBP) Acceleration Index (ACl) Diastolic Blood Pressure (DBP) Heather Index (HI) Mean Arterial Pressure (MAP) Pre-Ejection Period (PEP) Pulse Wave Velocity (PWV) Left Ventricular Ejection lime (LVET) Oxygen Delivery Index (D001 Thoracic Fluid Content (IFO) Stroke Volume (SV) Thoracic Fluid Content Index (TFCI) Stroke Index (SI) Baseline Impedance (ZO) Cardiac Output (00) Total Arterial Compliance (TAO) Cardiac Index (Cl) Total Arterial Compliance Index (TAO 1) Systemic Vascular Resistance (SVR) Systolic Time Ratio (STR) Systemic Vascular Resistance Index Systolic Time Ratio Index (STRI) (SVRI) Left Cardiac Work (LCW) Left Cardiac Work Index (LOWI) The Bio Z Cardio Profile Hemodynamic Monitor is not intended to be used as a vital sign monitor.

Source page: https://510kreport.com/device/K110645
Methodology: https://510kreport.com/methodology