Cleared Traditional

K882494 - ELAN-E DISPOSALBE DRAPE

K882494 is an FDA 510(k) clearance for ELAN-E DISPOSALBE DRAPE, manufactured by Dermacare Products, Inc.. The device is a Class 2 General Hospital device with product code KKX cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K882494 · Dermacare Products, Inc. · General Hospital
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Jul 1988
Decision
22d
Days
Class 2
Risk

K882494 is an FDA 510(k) clearance for the ELAN-E DISPOSALBE DRAPE. Classified as Drape, Surgical (product code KKX), Class II - Special Controls.

Submitted by Dermacare Products, Inc. (Louisville, US). The FDA issued a Cleared decision on July 8, 1988 after a review of 22 days - a notably fast clearance cycle.

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: 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 Dermacare Products, Inc. devices

FDA 510(k) Submission Details - K882494

510(k) Number K882494 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 16, 1988
Decision Date July 08, 1988
Days to Decision 22 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
107d faster than avg
Panel avg: 129d · This submission: 22d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KKX Device Classification - Class 2, Special Controls

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 292
Devices cleared under the same product code (KKX) and FDA review panel - the closest regulatory comparables to K882494.
O.R. TOWELS (STERILE)
K890709 · Cypress Medical Products, Ltd. · Mar 1989
AM TM SYRGICAL DRAPES
K882643 · Henley Intl. · Mar 1989
PMS ANGIO DRAPE
K890471 · Professional Medical Services · Feb 1989
3M BRAND LASER PROTECTION SURGICAL DRAPES, 88XX
K874086 · 3M Company · Dec 1987
LASER RESISTANT DRAPE
K873141 · Baxter Healthcare Corp · Oct 1987
OPSITE SPECIALITY DRAPES
K872757 · Smith & Nephew, Inc. · Jul 1987