Cleared Traditional

K850960 - NON-ABSORBENT DRAPES & ABSORBENT TOWELS

K850960 is an FDA 510(k) clearance for NON-ABSORBENT DRAPES & ABSORBENT TOWELS, manufactured by Excel Health Care Products. The device is a Class 2 General Hospital device with product code KKX cleared through the Traditional 510(k) pathway after a 372-day FDA review.

K850960 · Excel Health Care Products · General Hospital
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Mar 1986
Decision
372d
Days
Class 2
Risk

K850960 is an FDA 510(k) clearance for the NON-ABSORBENT DRAPES & ABSORBENT TOWELS. Classified as Drape, Surgical (product code KKX), Class II - Special Controls.

Submitted by Excel Health Care Products (S. Plainfield, US). The FDA issued a Cleared decision on March 15, 1986 after a review of 372 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Excel Health Care Products devices

FDA 510(k) Submission Details - K850960

510(k) Number K850960 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 1985
Decision Date March 15, 1986
Days to Decision 372 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
243d slower than avg
Panel avg: 129d · This submission: 372d
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 293
Devices cleared under the same product code (KKX) and FDA review panel - the closest regulatory comparables to K850960.
STERILE TOWEL W/ANTIMICROBIAL AGENT
K861969 · Deroyal Industries, Inc. · Jun 1986
STERILE STOCKINETTE W/ANTIMICROBIAL AGENT
K861196 · Deroyal Industries, Inc. · Apr 1986
ABSORBENT, FIBER, OPERATING ROOM TOWELS
K860936 · Ulti-Med Intl., Inc. · Apr 1986
TUBULAR ORTHO. STOCKINETTE W/ANTIMICROBIAL AGENT
K860326 · Deroyal Industries, Inc. · Feb 1986
100% COTTON ABSORBENT TOWEL
K860248 · Devon Industries, Inc. · Feb 1986
STANGUARD O.R. TOWEL PACK-4TOWEL PACK #278220400
K860447 · Standard Textile Co., Inc. · Feb 1986