Cleared Traditional

K042526 - DRAPE, SURGICAL, X-RAY ELEMENT, MODELS NON STERILE 6120-00, STERILE 704-B, NON STERILE 6124-00X, STERILE 704-BX

K042526 is an FDA 510(k) clearance for DRAPE, manufactured by Medical Action Industries, Inc.. The device is a Class 2 General Hospital device with product code KKX cleared through the Traditional 510(k) pathway after a 220-day FDA review.

K042526 · Medical Action Industries, Inc. · General Hospital
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Apr 2005
Decision
220d
Days
Class 2
Risk

K042526 is an FDA 510(k) clearance for the DRAPE, SURGICAL, X-RAY ELEMENT, MODELS NON STERILE 6120-00, STERILE 704-B, NO.... Classified as Drape, Surgical (product code KKX), Class II - Special Controls.

Submitted by Medical Action Industries, Inc. (Arden, US). The FDA issued a Cleared decision on April 25, 2005 after a review of 220 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Medical Action Industries, Inc. devices

FDA 510(k) Submission Details - K042526

510(k) Number K042526 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 17, 2004
Decision Date April 25, 2005
Days to Decision 220 days
Submission Type Traditional
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
91d slower than avg
Panel avg: 129d · This submission: 220d
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 269
Devices cleared under the same product code (KKX) and FDA review panel - the closest regulatory comparables to K042526.
MICROTEK EQUIPMENT DRAPES
K050322 · Microtek Medical, Inc. · May 2005
LASIK EYE DRAPE
K042977 · Odyssey Medical, Inc. · May 2005
HVO, INC., DISPOSABLE NON-STERILE SURGICAL DRAPES
K050508 · Haywood Vocational Opportunities · Apr 2005
MEDLINE STERILE DISPOSABLE SURGICAL GOWNS/DRAPES
K032666 · Medline Industries, Inc. · Mar 2005
UNDER BUTTOCKS DRAPE
K042893 · International Medsurg Connection, Inc. · Mar 2005
FOOTHILLS SURGICAL DRAPES
K041224 · Foothills Industries, Inc. · Feb 2005