Skip to content

Sorenson Thermodilution Cardiac Comput

by Sorensen Research

510(k) K812757

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK812757 Date2 Nov 1981ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
DXG
Device Class
Class II
Regulation
21 CFR Part 870.1435
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Sorenson Thermodilution Cardiac Comput is a pre-programmed, single-function diagnostic computer designed for thermodilution cardiac output measurement. It employs the thermodilution technique to determine cardiac output by injecting a cold solution into the right heart and measuring the temperature change in the pulmonary artery. This device supports simultaneous assessment of hemodynamic parameters, including pulmonary artery pressure, pulmonary capillary wedge pressure, and right atrial pressure, via a single flow-directed catheter.

This device is intended for use in clinical settings, such as intensive care units, for critically ill patients. It is supplied as a reusable medical instrument and has received FDA 510(k) clearance under the classification of Class II (DXG). The device operates in conjunction with a right heart catheter and does not require MRI compatibility considerations. Storage and handling follow standard medical device protocols for reusable diagnostic equipment, adhering to regulatory guidelines for maintenance and sterilization where applicable.

Other devices from Sorensen Research

See all devices from Sorensen Research →