Cleared Traditional

K802652 - BOUNDARY SURGICAL DRAPES WITH ADHESIVE

K802652 is an FDA 510(k) clearance for BOUNDARY SURGICAL DRAPES WITH ADHESIVE, manufactured by Procter & Gamble Mfg. Co.. The device is a Class 2 General Hospital device with product code KKX cleared through the Traditional 510(k) pathway after a 19-day FDA review.

K802652 · Procter & Gamble Mfg. Co. · General Hospital
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Nov 1980
Decision
19d
Days
Class 2
Risk

K802652 is an FDA 510(k) clearance for the BOUNDARY SURGICAL DRAPES WITH ADHESIVE. Classified as Drape, Surgical (product code KKX), Class II - Special Controls.

Submitted by Procter & Gamble Mfg. Co. (Mchenry, US). The FDA issued a Cleared decision on November 12, 1980 after a review of 19 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 Procter & Gamble Mfg. Co. devices

FDA 510(k) Submission Details - K802652

510(k) Number K802652 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 24, 1980
Decision Date November 12, 1980
Days to Decision 19 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
110d faster than avg
Panel avg: 129d · This submission: 19d
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 264
Devices cleared under the same product code (KKX) and FDA review panel - the closest regulatory comparables to K802652.
METALLINE DRESSINGS
K802787 · Secol Co. · Dec 1980
O.R. DRAPES
K802797 · Secol Co. · Dec 1980
DISPOSABLE SURGICAL DRAPE
K802537 · Texas Medical Products, Inc. · Nov 1980
COMFORT CUSHION DRY BURN PADS, STERILE
K802317 · American Convertors Div., American Pharmaseal · Oct 1980
DISP. FENESTRATED SURG. DRAPE SHEETS
K802359 · American Convertors Div., American Pharmaseal · Oct 1980
WHITE KNIGHT BOVIE CORD/SUCTION TUBE
K802213 · G.D. Searle and Co. · Oct 1980