Cleared Traditional

K140387 - Burn Resuscitation Decision Support System - Clinical (BRDSS-C) (FDA 510(k) Clearance)

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

K140387 · The Surgeon General, Department of the Army · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2014
Decision
312d
Days
Class 2
Risk

K140387 is an FDA 510(k) clearance for the Burn Resuscitation Decision Support System - Clinical (BRDSS-C). Classified as Burn Resuscitation Decision Support Software (product code PDT), Class II - Special Controls.

Submitted by The Surgeon General, Department of the Army (Fort Detrick, US). The FDA issued a Cleared decision on December 23, 2014 after a review of 312 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 The Surgeon General, Department of the Army devices

Submission Details

510(k) Number K140387 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 14, 2014
Decision Date December 23, 2014
Days to Decision 312 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
198d slower than avg
Panel avg: 114d · This submission: 312d
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.