PDT

Burn Resuscitation Decision Support Software

Product code

PDT

Device name

Burn Resuscitation Decision Support Software

Device class

Class 2

21 CFR

21 CFR 868.1890

Medical specialty

Anesthesiology

Marketing pathway

510(K)

Flag

Third-party review eligible

510(k) clearances (all years, FDA)

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

FDA classification definition

The burn resuscitation decision support system (BRDSS) is intended for use in prediction of hourly fluid volume during initial 24 hours of burn resuscitation. It is intended for patients who have greater than 20% total body surface area burn.

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