# K140387: Burn Resuscitation Decision Support System - Clinical (BRDSS-C)

- Pathway: 510(k) (Traditional)
- Applicant: The Surgeon General, Department of the Army
- Decided: Dec 23, 2014 after 312 days
- Product code: PDT (Burn Resuscitation Decision Support Software)
- Device class: 2
- Regulation: 21 CFR 868.1890
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K011571 (2001). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121659: Burn Resuscitation Decision Support System (Brdss), Arcos, Inc. (2013) Summary page 5.

## Indications for use
The BRDSS-C is indicated for use in the care of adult patients and adolescent patients 17 years of age or older who weigh 40kg (88lbs) or more with 20% or more Total Body Surface Area (TBSA) burned, as a fluid resuscitation calculator for fluid recommendations. The BRDSS-C is intended to be initiated within 24 hours of the burn incident and completed by 72 hours post burn. The BRDSS-C is not indicated for use in patients who are less than 17 years of age.

Source page: https://510kreport.com/device/K140387
Methodology: https://510kreport.com/methodology