Cleared Traditional

K121659 - BURN RESUSCITATION DECISION SUPPORT SYSTEM (BRDSS) (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K121659 · Arcos, Inc. · General & Plastic Surgery device
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Apr 2013
Decision
317d
Days
Class 2
Risk

K121659 is an FDA 510(k) clearance for the BURN RESUSCITATION DECISION SUPPORT SYSTEM (BRDSS). Classified as Burn Resuscitation Decision Support Software (product code PDT), Class II - Special Controls.

Submitted by Arcos, Inc. (Houston, US). The FDA issued a Cleared decision on April 18, 2013 after a review of 317 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 868.1890 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Arcos, Inc. devices

Submission Details

510(k) Number K121659 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 05, 2012
Decision Date April 18, 2013
Days to Decision 317 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
202d slower than avg
Panel avg: 115d · This submission: 317d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PDT Burn Resuscitation Decision Support Software
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1890
Definition 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.