Cleared Traditional

K800928 - WHITE KNIGHT SUPPLEMENTAL DRAPE

K800928 is an FDA 510(k) clearance for WHITE KNIGHT SUPPLEMENTAL DRAPE, manufactured by G.D. Searle and Co.. The device is a Class 2 General Hospital device with product code KKX cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K800928 · G.D. Searle and Co. · General Hospital
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May 1980
Decision
29d
Days
Class 2
Risk

K800928 is an FDA 510(k) clearance for the WHITE KNIGHT SUPPLEMENTAL DRAPE. Classified as Drape, Surgical (product code KKX), Class II - Special Controls.

Submitted by G.D. Searle and Co. (Mchenry, US). The FDA issued a Cleared decision on May 20, 1980 after a review of 29 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 G.D. Searle and Co. devices

FDA 510(k) Submission Details - K800928

510(k) Number K800928 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 21, 1980
Decision Date May 20, 1980
Days to Decision 29 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
100d faster than avg
Panel avg: 129d · This submission: 29d
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 228
Devices cleared under the same product code (KKX) and FDA review panel - the closest regulatory comparables to K800928.
TACKMER INCISE DRAPE
K802050 · American Convertors Div., American Pharmaseal · Sep 1980
BARRIER TOWEL DRAPE
K801863 · Surgikos, Inc. · Aug 1980
BARRIER APERTURED DRAPE
K801864 · Surgikos, Inc. · Aug 1980
BOUNDARY EXTREMITY DRAPE
K801132 · Procter & Gamble Mfg. Co. · May 1980
SHIELD DISP. REINFORCED DRAPE SHEETS
K800817 · American Convertors Div., American Pharmaseal · May 1980
ZEISS DISPOSABLE, STERILE SURGICAL DRAPE
K800552 · Carl Zeiss, Inc. · Mar 1980