510(k) · Cleared

Recalled · Class II · 2015

Burn Resuscitation Decision Support System (Brdss)

K121659510(k) TraditionalCleared Apr 18, 2013317-day reviewClass II21 CFR 868.1890Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Arcos, Inc. · PDT Burn Resuscitation Decision Support Software

Cleared on Apr 18, 2013 as substantially equivalent to K011571 (The RX Files Corp., 2001) after a 317-day review. Its family tree reaches back 1 generation to 2001. 1 later device descends from it. It has been recalled once.

Decided: Apr 18, 2013
Review: 317 days
Class: Class II
Product code: PDT
Recalls: 1
Predicates: 1

Its longest line of descent runs back 1 generation to K011571 (2001). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK011571 TRXF Intelligent Dosing System (Ids) -Dosing Calculator SuiteThe RX Files Corp. · 2001
This deviceK121659 Burn Resuscitation Decision Support System (Brdss)Arcos, Inc. · 2013
Descendant · cites it directly · 0 of its ownK140387 Burn Resuscitation Decision Support System - Clinical (BRDSS-C)The Surgeon General, Department of the Army · 2014

Most influential descendants

Showing 1 of 1 · See all

K140387Burn Resuscitation Decision Support System - Clinical (BRDSS-C)The Surgeon General, Department of the Army · 2014 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K011571	TRXF Intelligent Dosing System (Ids) -Dosing Calculator Suite	The RX Files Corp.	2001	—
0 (this device)	K121659	Burn Resuscitation Decision Support System (Brdss)	Arcos, Inc.	2013	—
+1	K140387	Burn Resuscitation Decision Support System - Clinical (BRDSS-C)	The Surgeon General, Department of the Army	2014	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2014	1	0

FIG. 1 — Lineage of K121659, 2001–2014Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in PDT? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K011571	TRXF Intelligent Dosing System (Ids) -Dosing Calculator Suite Summary page 1 …bum. Substantial Equivalence A. Predicate Device Cornparison Predicate Device Applicant K(011571 Burn Resuscitation Decision Support TRxF Intelligent Dosing System…	The RX Files Corp.	2001	—

Also cleared against K011571: 4 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K140387	Burn Resuscitation Decision Support System - Clinical (BRDSS-C)	The Surgeon General, Department of the Army	2014	0

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Mar 16, 2015	Class II	Z-2295-2019	Component design/selection	Battery packs may heat up abnormally and ignite in rare instance.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.
Of its descendants, K140387 (The Surgeon General, Department of the Army, 2014) has gone furthest, with 0 descendants of its own.
4 other devices also cite its predicate K011571.

How does its category compare?

All PDT devices

PDT Burn Resuscitation Decision Support Software: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.

FDA decisions per year · PDT

1in 2014

2007high 1 (2013) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · PDT

Too few PDT 510(k)s in any year since 2007 to give a median.

Recalls per year · PDT

No recall names PDT since 2007.

Adverse event reports per year · PDT

No MAUDE report names PDT since 2007.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	0
2008	0	—	0
2009	0	—	0
2010	0	—	0
2011	0	—	0
2012	0	—	0
2013	1	—	0
2014	1	—	0
2015	0	—	0
2016	0	—	0
2017	0	—	0
2018	0	—	0
2019	0	—	0
2020	0	—	0
2021	0	—	0
2022	0	—	0
2023	0	—	0
2024	0	—	0
2025	0	—	0
2026	0	—	—

What is it indicated for?

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.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K121659 · printed Nov 6, 2026

Cite this page

510(k) Report. “K121659: Burn Resuscitation Decision Support System (Brdss).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121659

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026