Cleared Traditional

K860248 - 100% COTTON ABSORBENT TOWEL

K860248 is an FDA 510(k) clearance for 100% COTTON ABSORBENT TOWEL, manufactured by Devon Industries, Inc.. The device is a Class 2 General Hospital device with product code KKX cleared through the Traditional 510(k) pathway after a 26-day FDA review.

K860248 · Devon Industries, Inc. · General Hospital
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Feb 1986
Decision
26d
Days
Class 2
Risk

K860248 is an FDA 510(k) clearance for the 100% COTTON ABSORBENT TOWEL. Classified as Drape, Surgical (product code KKX), Class II - Special Controls.

Submitted by Devon Industries, Inc. (Chatsworth, US). The FDA issued a Cleared decision on February 19, 1986 after a review of 26 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 Devon Industries, Inc. devices

FDA 510(k) Submission Details - K860248

510(k) Number K860248 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 24, 1986
Decision Date February 19, 1986
Days to Decision 26 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
103d faster than avg
Panel avg: 129d · This submission: 26d
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 164
Devices cleared under the same product code (KKX) and FDA review panel - the closest regulatory comparables to K860248.
STERILE TOWEL W/ANTIMICROBIAL AGENT
K861969 · Deroyal Industries, Inc. · Jun 1986
STERILE STOCKINETTE W/ANTIMICROBIAL AGENT
K861196 · Deroyal Industries, Inc. · Apr 1986
TUBULAR ORTHO. STOCKINETTE W/ANTIMICROBIAL AGENT
K860326 · Deroyal Industries, Inc. · Feb 1986
ABCO DRAPES/TOWELS
K851314 · Abco Dealers, Inc. · May 1985
SURGICAL DRAPES
K844802 · Procter & Gamble Mfg. Co. · Jan 1985
DRAPE SURGICAL UTILITY DRAPE STERILE
K843496 · Busse Hospital Disposables, Inc. · Oct 1984