# K121659: Burn Resuscitation Decision Support System (Brdss)

- Pathway: 510(k) (Traditional)
- Applicant: Arcos, Inc.
- Decided: Apr 18, 2013 after 317 days
- Product code: PDT (Burn Resuscitation Decision Support Software)
- Device class: 2
- Regulation: 21 CFR 868.1890
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K011571 (2001). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011571: TRXF Intelligent Dosing System (Ids) -Dosing Calculator Suite, The RX Files Corp. (2001) Summary page 1.

## Most influential descendants
- K140387: Burn Resuscitation Decision Support System - Clinical (BRDSS-C) (2014), 0 descendants of its own

## Recalls of this device
- Mar 16, 2015 · Class II · Z-2295-2019: Battery packs may heat up abnormally and ignite in rare instance.

## Indications for use
The Burn Resuscitation Decision Support System (BRDSS) is indicated for use in the care of adult patients with 20% or more Total Body Surface Area (TBSA) burned, as a fluid resuscitation calculator for hourly fluid recommendations. The BRDSS is intended to be initiated within 24 hours of the burn incident and ending by 72 hours post burn.

Source page: https://510kreport.com/device/K121659
Methodology: https://510kreport.com/methodology