510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K121659Substantially Equivalent

Burn Resuscitation Decision Support System (Brdss)

Arcos, Inc., Houston TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K121659 is the FDA 510(k) clearance record for BURN RESUSCITATION DECISION SUPPORT SYSTEM (BRDSS), a class II device, cleared for Arcos, Inc. on under FDA product code PDT (Burn Resuscitation Decision Support Software). FDA's definition for product code PDT reads: "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...". FDA records list one 510(k) clearance for Arcos, Inc. As of , FDA records show one recall naming K121659.

Clearance record

Decision date
Received
(317 days to decision)
Product code
PDT Burn Resuscitation Decision Support Software
Regulation
21 CFR 868.1890
Device class
Class II
Review panel
Anesthesiology
Applicant
Arcos, Inc. 866 W. 41st, Houston TX
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PDT

Trailing 12 months

FDA records hold no clearances under product code PDT in the trailing twelve months.

FDA records show no clearances under product code PDT in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code PDT, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260