# K051228: Biozdx Hemodynamic Monitor and 12-Lead Ecg

- Pathway: 510(k) (Traditional)
- Applicant: Cardiodynamics International Corp.
- Decided: Jun 10, 2005 after 28 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: 3 generations back to K895520 (1990). 7 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041294: Biozdx Hemodynamic Monitor, Cardiodynamics International Corp. (2004) Summary page 1.
- K031422: Philips Page Writer Trim Series Cardiograph Including I, II, Iii, Models 860286, 860287, 860288, 860289, 860290, 860291, Philips Medical Systems (2003) Summary page 1.

## Most influential descendants
- K070156: Bioz DX Hemodynamic Monitor with Philips 12-Lead Ecg, Model 5100 (2007), 4 descendants of its own
- 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
The BioZDx Hemodynamic Monitor is intended to monitor and display a patient's hemodynamic parameters. These parameters include: ECG Pre-Ejection Period Systolic Time Ratio Cardiac Output Heart Rate End diastolic Index Thoracic Fluid Content Acceleration Index Cardiac Index Left Vent. Ejection Time Index of Contractility End Diastolic Volume Mean Blood Pressure Stroke Volume Systemic Vascular Resistance Systolic Blood Pressure Left Cardiac Work Diastolic Blood Pressure 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/K051228
Methodology: https://510kreport.com/methodology