510(k) Report

FDA product code · General and plastic surgery

Burn Resuscitation Decision Support Software

PDTClass II21 CFR 868.1890510(k) required2 decisions since 20130 recalls

2 FDA decisions since 2013. No recall names this code. The most-cited predicate is K121659, named by 1 later device.

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.

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

FIG. A — Illustration, general and plastic surgery panel

Twenty years of PDT at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

FDA decisions per year · PDT

1in 2014

2013: 12014: 1
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20131—00
20141—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—
FIG. 1 — PDT by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in PDT? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which predicates do PDT devices cite most?

Devices in this code that later submissions most often claim equivalence to.

  • K121659Burn Resuscitation Decision Support System (Brdss)Arcos, Inc. · 20131cites it

Which PDT devices have the deepest lineage?

Devices in this code with the longest line of descent behind them.

  • K140387Burn Resuscitation Decision Support System - Clinical (BRDSS-C)The Surgeon General, Department of the Army · 20142generations
  • K121659Burn Resuscitation Decision Support System (Brdss)Arcos, Inc. · 20131generation

What has FDA decided in PDT lately?

  • K140387Burn Resuscitation Decision Support System - Clinical (BRDSS-C)The Surgeon General, Department of the Army · 2014
  • K121659Burn Resuscitation Decision Support System (Brdss)Arcos, Inc. · 20131 recall

All 2 PDT decisions →

Related product codes

Other codes under 21 CFR 868.1890.

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