Cleared Traditional

K012237 - MERTEX-PLUS REUSABLE SURGICAL DRAPE

K012237 is an FDA 510(k) clearance for MERTEX-PLUS REUSABLE SURGICAL DRAPE, manufactured by Mercan AB. The device is a Class 2 General Hospital device with product code KKX cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K012237 · Mercan AB · General Hospital
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Oct 2001
Decision
90d
Days
Class 2
Risk

K012237 is an FDA 510(k) clearance for the MERTEX-PLUS REUSABLE SURGICAL DRAPE. Classified as Drape, Surgical (product code KKX), Class II - Special Controls.

Submitted by Mercan AB (Austin, US). The FDA issued a Cleared decision on October 15, 2001 after a review of 90 days - within the typical 510(k) review window.

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 Mercan AB devices

FDA 510(k) Submission Details - K012237

510(k) Number K012237 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 17, 2001
Decision Date October 15, 2001
Days to Decision 90 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 129d · This submission: 90d
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 250
Devices cleared under the same product code (KKX) and FDA review panel - the closest regulatory comparables to K012237.
MEDLINE ASEP PLUS SURGICAL DRAPES
K023432 · Medline Industries, Inc. · Nov 2002
WOUND PROTECTOR/RETRACTOR
K020435 · Applied Medical Resources Corp. · Apr 2002
TOWEL DRAPE, MODELS 4409, 4410
K012957 · Dynarex Corp. · Mar 2002
MODIFICATION TO: COMPEL SURGICAL DRAPES
K012807 · Standard Textile Co., Inc. · Oct 2001
ADVANCE MEDICAL DESIGNS FLUID POUCH
K012168 · Advance Medical Designs, Inc. · Sep 2001
SURGICAL DRAPES
K011422 · Advance Medical Designs, Inc. · Jul 2001