Cleared Traditional

BURNSHIELD FIRE BLANKET (K921470) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K921470 · Levtrade Intl. (Pty) , Ltd. · General & Plastic Surgery device
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Apr 1993
Decision
389d
Days
Class 1
Risk

K921470 is an FDA 510(k) clearance for the BURNSHIELD FIRE BLANKET. Classified as Sheet, Burn (product code FPY), Class I - General Controls.

Submitted by Levtrade Intl. (Pty) , Ltd. (Petoria, South Africa, ZA). The FDA issued a Cleared decision on April 20, 1993 after a review of 389 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 880.5180 - 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 Levtrade Intl. (Pty) , Ltd. devices

Submission Details

510(k) Number K921470 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 27, 1992
Decision Date April 20, 1993
Days to Decision 389 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
274d slower than avg
Panel avg: 115d · This submission: 389d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FPY Sheet, Burn
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.5180
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.