Cleared Traditional

K921470 - BURNSHIELD FIRE BLANKET

K921470 is an FDA 510(k) clearance for BURNSHIELD FIRE BLANKET, manufactured by Levtrade Intl. (Pty) , Ltd.. The device is a Class 1 General & Plastic Surgery device with product code FPY cleared through the Traditional 510(k) pathway after a 389-day FDA review.

K921470 · Levtrade Intl. (Pty) , Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K921470

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.

FPY Device Classification - Class 1, General Controls

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.

Regulatory Peers - FPY Sheet, Burn

Devices cleared under the same product code (FPY) and FDA review panel - the closest regulatory comparables to K921470.
LYOSHEET SURGICAL SHEET FOR BURNS
K871740 · Acme United Corp. · Jun 1987
KENDALL CURITY BURN PAD
K853145 · The Kendal Co. · Aug 1985
ABSORB FURN SHEET
K820994 · American Convertors Div., American Pharmaseal · May 1982
TEMPORARY BURN SHEET WITH PERFORATED
K792432 · American Medical Disposable, Inc. · Dec 1979
TEMPORARY BURN SHEET WITH PERFORATED
K792433 · American Medical Disposable, Inc. · Dec 1979