Cleared Special

K023432 - MEDLINE ASEP PLUS SURGICAL DRAPES

K023432 is an FDA 510(k) clearance for MEDLINE ASEP PLUS SURGICAL DRAPES, manufactured by Medline Industries, Inc.. The device is a Class 2 General Hospital device with product code KKX cleared through the Special 510(k) pathway after a 20-day FDA review.

K023432 · Medline Industries, Inc. · General Hospital
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Nov 2002
Decision
20d
Days
Class 2
Risk

K023432 is an FDA 510(k) clearance for the MEDLINE ASEP PLUS SURGICAL DRAPES. Classified as Drape, Surgical (product code KKX), Class II - Special Controls.

Submitted by Medline Industries, Inc. (Mundelein, US). The FDA issued a Cleared decision on November 4, 2002 after a review of 20 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K023432

510(k) Number K023432 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 2002
Decision Date November 04, 2002
Days to Decision 20 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
109d faster than avg
Panel avg: 129d · This submission: 20d
Pathway characteristics
Modification to existing cleared device.

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 449
Devices cleared under the same product code (KKX) and FDA review panel - the closest regulatory comparables to K023432.
PRIMAGARD SURGICAL EQUIPMENT DRAPES
K022868 · Primeline Medical Products, Inc. · Nov 2002
PRIMAGARD SURGICAL GOWNS
K023117 · Primeline Medical Products, Inc. · Nov 2002
DRAPES WITH ABSORBENT REINFORCEMENT
K023425 · Allegiance Healthcare Corp. · Nov 2002
PRIMAGARD NONSTERILE FEMORAL ANGIOGRAPHY DRAPES (MODELS PM1-0136, PM1-0119, PM1-0142)
K021864 · Primeline Medical Products, Inc. · Sep 2002
COLOSHIELD COLONOSCOPY DRAPE MODEL E2000
K020581 · Medical Concepts Development, Inc. · Sep 2002
INDUS TEXTILES TOWEL-STERILE AND NON-STERILE
K013958 · Indus Textiles, Inc. · Aug 2002
K023432 · MEDLINE ASEP PLUS SURGICAL DRAPES
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