QMS

Adjunctive Open Loop Fluid Therapy Recommender

Product code

QMS

Device name

Adjunctive Open Loop Fluid Therapy Recommender

Device class

Class 2

21 CFR

21 CFR 870.5600

Medical specialty

Cardiovascular

Marketing pathway

510(K)

Flag

Third-party review eligible

510(k) clearances (last 3 years)

1

Summaries archived here

1 (direct download)

510(k) clearances (all years, FDA)

2 (all years; only the last 3 years are listed here)

FDA classification definition

The adjunctive open loop fluid therapy recommender is a prescription device that uses software algorithms to analyze cardiovascular vital signs and predict a patient’s estimated response to fluid therapy. The device is intended for adjunctive use with other physical vital sign parameters and patient information and is not intended to independently direct therapy.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2024-08-02.

1 summaries are archived here for direct download.