Cleared Traditional

K850960 - NON-ABSORBENT DRAPES & ABSORBENT TOWELS

K850960 is the FDA 510(k) clearance for NON-ABSORBENT DRAPES & ABSORBENT TOWELS by Excel Health Care Products. It is a Class 2 General Hospital device (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

Submission Details

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.

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 65
Devices cleared under the same product code (KKX) and FDA review panel - the closest regulatory comparables to K850960.
SPUNGUARD PLUS SURGICAL DRAPE
K862801 · Kimberly-Clark Corp. · Aug 1986
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