Cleared Traditional

K984082 - BURN-AID HYDROGEL, BURN-AID BURN DRESSING, BURN-AID BURN BLANKET (FDA 510(k) Clearance)

K984082 · Emox 911 CC · General & Plastic Surgery device
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Jan 1999
Decision
73d
Days
-
Risk

K984082 is an FDA 510(k) clearance for the BURN-AID HYDROGEL, BURN-AID BURN DRESSING, BURN-AID BURN BLANKET. Classified as Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic (product code MGQ).

Submitted by Emox 911 CC (Somerset West, ZA). The FDA issued a Cleared decision on January 28, 1999 after a review of 73 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Emox 911 CC devices

Submission Details

510(k) Number K984082 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 16, 1998
Decision Date January 28, 1999
Days to Decision 73 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 114d · This submission: 73d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MGQ Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic
Device Class -