Cleared Traditional

K813419 - COMFORT CUSHION DRY BURN PAD III

K813419 is an FDA 510(k) clearance for COMFORT CUSHION DRY BURN PAD III, manufactured by American Convertors Div., American Pharmaseal. The device is a Class 1 General & Plastic Surgery device with product code NAB cleared through the Traditional 510(k) pathway after a 46-day FDA review.

K813419 · American Convertors Div., American Pharmaseal · General & Plastic Surgery device
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Jan 1982
Decision
46d
Days
Class 1
Risk

K813419 is an FDA 510(k) clearance for the COMFORT CUSHION DRY BURN PAD III. Classified as Gauze / Sponge,nonresorbable For External Use (product code NAB), Class I - General Controls.

Submitted by American Convertors Div., American Pharmaseal (Mchenry, US). The FDA issued a Cleared decision on January 22, 1982 after a review of 46 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4014 - 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 American Convertors Div., American Pharmaseal devices

FDA 510(k) Submission Details - K813419

510(k) Number K813419 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 07, 1981
Decision Date January 22, 1982
Days to Decision 46 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
69d faster than avg
Panel avg: 115d · This submission: 46d
Pathway characteristics
Predicate-based equivalence.

NAB Device Classification - Class 1, General Controls

Product Code NAB Gauze / Sponge,nonresorbable For External Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4014
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 - NAB Gauze / Sponge,nonresorbable For External Use

All 33
Devices cleared under the same product code (NAB) and FDA review panel - the closest regulatory comparables to K813419.
VAG PACKING
K820096 · Stan-Pak Ent. · Feb 1982
SHEET WADDING CAST PADDING
K820097 · Stan-Pak Ent. · Feb 1982
ROLLER GAUZE
K820098 · Stan-Pak Ent. · Feb 1982
TRIANGULAR BANDAGE
K811814 · Abco Dealers, Inc. · Jul 1981
BONE-DRI SURGICAL SPONGE
K803125 · Howmedica Corp. · Jan 1981
GUAZE BANDAGES CAT.#101-169
K801996 · Pollak (Intl.), Ltd. · Sep 1980