Cleared Traditional

K813360 - DERMAFILE (CAT. # 38

K813360 is the FDA 510(k) clearance for DERMAFILE (CAT. # 38 by Exco, Inc.. It is a Class 2 General Hospital device (product code KKX) cleared through the Traditional 510(k) pathway after a 108-day FDA review.

K813360 · Exco, Inc. · General Hospital
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Mar 1982
Decision
108d
Days
Class 2
Risk

K813360 is an FDA 510(k) clearance for the DERMAFILE (CAT. # 38. Classified as Drape, Surgical (product code KKX), Class II - Special Controls.

Submitted by Exco, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 18, 1982 after a review of 108 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.4370 - the FDA general hospital 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. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Exco, Inc. devices

Submission Details

510(k) Number K813360 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 30, 1981
Decision Date March 18, 1982
Days to Decision 108 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
21d faster than avg
Panel avg: 129d · This submission: 108d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KKX Drape, Surgical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4370
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - KKX Drape, Surgical

All 66
Devices cleared under the same product code (KKX) and FDA review panel - the closest regulatory comparables to K813360.
SINGLE-USE SURGICAL DRAPES
K833877 · Procter & Gamble Mfg. Co. · Jan 1984
LIGHT HANDLE COVER
K832278 · Concept, Inc. · Sep 1983
GORE-TEX BARRIER SURG. DRAPES & GOWNS
K822641 · W.L. Gore & Associates, Inc. · Jan 1983
STERILE ADHERENT DRAPES
K812809 · Abco Dealers, Inc. · Nov 1981
3M GERMICIDAL SURGICAL INCISE DRAPE
K801550 · 3M Company · Sep 1981
BOUNDARY SURGICAL DRAPES WITH ADHESIVE
K802652 · Procter & Gamble Mfg. Co. · Nov 1980