Cleared Traditional

K802280 - WHITE KNIGHT DRAPE SEAL

K802280 is an FDA 510(k) clearance for WHITE KNIGHT DRAPE SEAL, 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 22-day FDA review.

K802280 · G.D. Searle and Co. · General Hospital
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Oct 1980
Decision
22d
Days
Class 2
Risk

K802280 is an FDA 510(k) clearance for the WHITE KNIGHT DRAPE SEAL. 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 October 10, 1980 after a review of 22 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 - K802280

510(k) Number K802280 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 1980
Decision Date October 10, 1980
Days to Decision 22 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
107d faster than avg
Panel avg: 129d · This submission: 22d
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 165
Devices cleared under the same product code (KKX) and FDA review panel - the closest regulatory comparables to K802280.
DISPOSABLE SURGICAL DRAPE
K802537 · Texas Medical Products, Inc. · Nov 1980
BOUNDARY SURGICAL DRAPES WITH ADHESIVE
K802652 · Procter & Gamble Mfg. Co. · Nov 1980
WHITE KNIGHT BOVIE CORD/SUCTION TUBE
K802213 · G.D. Searle and Co. · Oct 1980
BOUNDARY SINGLE-USE DRAPE
K802148 · Procter & Gamble Mfg. Co. · Sep 1980
BOUNDARY SINGLE-USE DRAPES
K802192 · Procter & Gamble Mfg. Co. · Sep 1980
BOUNDARY SINGLE-USE DRAPES
K802247 · Procter & Gamble Mfg. Co. · Sep 1980