Sorba Model CIC-1000 Non-Invasive Hemodynamic Monitor

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K950389 ↗

FDA Product Code

DSB

Device Class

Class II

Regulation

21 CFR Part 870.2770

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Sorba Steorra Non-Invasive Impedance Cardiograph

  Class II

  FDA 510(k) K014299 Active Cleared 30 Jan 2002

• Sorba Model Cic-1000 W/New Electrodes

  Class II

  FDA 510(k) K901926 Active Cleared 12 Jun 1990

• Sorba Model Cic-1000, Comp. Impedance Cardiograph

  Class II

  FDA 510(k) K895017 Active Cleared 14 Mar 1990

• What clinical settings is the Sorba Model CIC-1000 Non-Invasive Hemodynamic Monitor designed for use in?

  The Sorba Model CIC-1000 is specifically designed for clinical settings such as cardiovascular monitoring rooms and intensive care units. Its non-invasive hemodynamic monitoring capabilities make it suitable for environments where continuous assessment of cardiovascular parameters—like cardiac output and blood volume dynamics—is critical without the need for invasive procedures.

• Is the Sorba Model CIC-1000 a single-use or reusable device, and what does that mean for maintenance?

  The Sorba Model CIC-1000 is supplied as a reusable medical instrument. This means it is intended for repeated use across multiple patients, provided it undergoes proper cleaning, disinfection, and maintenance procedures as outlined by the manufacturer to ensure safety, functionality, and compliance with clinical standards.

• How is the regulatory status of the Sorba Model CIC-1000 determined, and what does that classification mean for users?

  The Sorba Model CIC-1000 is classified as a Class II device under FDA regulation number 870.2770 and holds a 510(k) clearance (K950389) with a decision date of August 15, 1995. This classification means it has undergone FDA review to ensure it is substantially equivalent to a legally marketed predicate device, providing users with assurance of its safety and effectiveness for its intended use as a non-invasive hemodynamic monitor.

• What types of cardiovascular parameters does the Sorba Model CIC-1000 measure, and how does it achieve this?

  The Sorba Model CIC-1000 measures cardiovascular parameters such as cardiac output and blood volume dynamics using impedance cardiography principles. This non-invasive technique assesses hemodynamic status by analyzing electrical impedance changes in the thoracic cavity, eliminating the need for invasive procedures like catheters or arterial lines.

• Are there any specific storage requirements or considerations for the Sorba Model CIC-1000?

  The provided data does not specify sterility or detailed storage instructions for the Sorba Model CIC-1000. However, as a reusable device, it should be stored in a clean, dry environment, protected from physical damage, and maintained according to the manufacturer’s guidelines to ensure optimal performance and longevity. Always follow the manufacturer’s instructions for proper handling and storage.