DeviceClearance

Product code PDT— Anesthesiology

BURN RESUSCITATION DECISION SUPPORT SYSTEM (BRDSS)

Classification name
Burn Resuscitation Decision Support Software
Device class
Class 2
Regulation
21 CFR 868.1890
Advisory panel
Anesthesiology
Total cleared
2
First cleared
Most recent

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.”

— U.S. Food and Drug Administration, device classification record for product code PDT under 21 CFR 868.1890, via openFDA

Market context for product code PDT

FDA has cleared 2 devices under product code PDT between 2013 and 2014, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code PDT

Recent clearances under product code PDT

Data sourced from openFDA. This site is unofficial and independent of the FDA.