Cleared Traditional

K780846 - DRAPING MATERIAL

K780846 is an FDA 510(k) clearance for DRAPING MATERIAL, manufactured by Kimberly-Clark Corp.. The device is a Class 2 General Hospital device with product code KKX cleared through the Traditional 510(k) pathway after a 26-day FDA review.

K780846 · Kimberly-Clark Corp. · General Hospital
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Jun 1978
Decision
26d
Days
Class 2
Risk

K780846 is an FDA 510(k) clearance for the DRAPING MATERIAL, COLBALT 60 STERILE. Classified as Drape, Surgical (product code KKX), Class II - Special Controls.

Submitted by Kimberly-Clark Corp. (Mchenry, US). The FDA issued a Cleared decision on June 19, 1978 after a review of 26 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 Kimberly-Clark Corp. devices

FDA 510(k) Submission Details - K780846

510(k) Number K780846 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 24, 1978
Decision Date June 19, 1978
Days to Decision 26 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
103d faster than avg
Panel avg: 129d · This submission: 26d
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 174
Devices cleared under the same product code (KKX) and FDA review panel - the closest regulatory comparables to K780846.
BARRIER OBSTETRICAL PACK FABRIC 450
K780844 · Surgikos, Inc. · Aug 1978
OP-SITE ADHESIVE DRAPES
K780853 · Acme United Corp. · Aug 1978
BARRIER GYNECOLOGY PACK FABRIC 450
K780856 · Surgikos, Inc. · Aug 1978
LEAD HAND
K772387 · Edward Weck, Inc. · Apr 1978
TOWEL, DRAPE, BOUNDARY
K780036 · Procter & Gamble Mfg. Co. · Jan 1978
SHAVE PREP TRAY
K771036 · Parke-Davis Co. · Jul 1977