# K014299: Sorba Steorra Non-Invasive Impedance Cardiograph

- Pathway: 510(k) (Special)
- Applicant: Sorba Medical Systems, Inc.
- Decided: Jan 30, 2002 after 30 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Steorra™ by SORBA is a noninvasive hemodynamic monitor based on the technology of impedance cardiography. The Steorra™ measures the following cardiac parameters: heart rate (HR); stroke volume (SV) and Cardiac Output (CO) The Steorra™ can be configured with optional noninvasive blood pressure (NIBP) technology. When blood pressure data are available (via the NIBP, analog input from an invasive monitor, or manual input), then systolic, diastolic and mean blood pressures are displayed with rate pressure product (RPP). If central venous pressure (CVP) is input as an analog signal from an invasive monitor, then CVP is displayed and systemic vascular resistance (SVR) is calculated and displayed.

Source page: https://510kreport.com/device/K014299
Methodology: https://510kreport.com/methodology