Cleared Traditional

K864899 - SURGICAL DRAPE PACK

K864899 is an FDA 510(k) clearance for SURGICAL DRAPE PACK, manufactured by Webster Enterprises, Inc.. The device is a Class 2 General Hospital device with product code KKX cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K864899 · Webster Enterprises, Inc. · General Hospital
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Jan 1987
Decision
36d
Days
Class 2
Risk

K864899 is an FDA 510(k) clearance for the SURGICAL DRAPE PACK. Classified as Drape, Surgical (product code KKX), Class II - Special Controls.

Submitted by Webster Enterprises, Inc. (Webster, US). The FDA issued a Cleared decision on January 20, 1987 after a review of 36 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 Webster Enterprises, Inc. devices

FDA 510(k) Submission Details - K864899

510(k) Number K864899 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 15, 1986
Decision Date January 20, 1987
Days to Decision 36 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
93d faster than avg
Panel avg: 129d · This submission: 36d
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 K864899.
OPSITE SPECIALITY DRAPES
K872757 · Smith & Nephew, Inc. · Jul 1987
DISPOSABLE LASER PROTECTIVE DRAPE FOR CO2 LASER
K871068 · Lifestream Int'L, Inc. · May 1987
MODIFIED DISPOSABLE STERILE TOWEL USED IN SURGERY
K864388 · Deroyal Industries, Inc. · Feb 1987
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