Cleared Traditional

K800064 - WATER JEL FIRE BLANKET

K800064 is an FDA 510(k) clearance for WATER JEL FIRE BLANKET, manufactured by Trilling Resources, Ltd.. The device is a Class 1 General & Plastic Surgery device with product code FPY cleared through the Traditional 510(k) pathway after a 74-day FDA review.

K800064 · Trilling Resources, Ltd. · General & Plastic Surgery device
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Mar 1980
Decision
74d
Days
Class 1
Risk

K800064 is an FDA 510(k) clearance for the WATER JEL FIRE BLANKET. Classified as Sheet, Burn (product code FPY), Class I - General Controls.

Submitted by Trilling Resources, Ltd. (Walker, US). The FDA issued a Cleared decision on March 25, 1980 after a review of 74 days - a notably fast clearance cycle.

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: 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 Trilling Resources, Ltd. devices

FDA 510(k) Submission Details - K800064

510(k) Number K800064 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 11, 1980
Decision Date March 25, 1980
Days to Decision 74 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 115d · This submission: 74d
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 K800064.
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