Cleared Traditional

K961067 - BURN-AID HYDROGEL,BURN DRESSING,BURN BLANKET (FDA 510(k) Clearance)

K961067 · Medtrak Intl., Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1996
Decision
59d
Days
-
Risk

K961067 is an FDA 510(k) clearance for the BURN-AID HYDROGEL,BURN DRESSING,BURN BLANKET. Classified as Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic (product code MGQ).

Submitted by Medtrak Intl., Inc. (Columbia, US). The FDA issued a Cleared decision on May 16, 1996 after a review of 59 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 Medtrak Intl., Inc. devices

Submission Details

510(k) Number K961067 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 1996
Decision Date May 16, 1996
Days to Decision 59 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
55d faster than avg
Panel avg: 114d · This submission: 59d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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