Cleared Traditional

K112378 - COBES SURGICAL DRAPE

K112378 is an FDA 510(k) clearance for COBES SURGICAL DRAPE, manufactured by Cobes Industries Co., Ltd.. The device is a Class 2 General Hospital device with product code KKX cleared through the Traditional 510(k) pathway after a 264-day FDA review.

K112378 · Cobes Industries Co., Ltd. · General Hospital
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May 2012
Decision
264d
Days
Class 2
Risk

K112378 is an FDA 510(k) clearance for the COBES SURGICAL DRAPE. Classified as Drape, Surgical (product code KKX), Class II - Special Controls.

Submitted by Cobes Industries Co., Ltd. (Dover, US). The FDA issued a Cleared decision on May 8, 2012 after a review of 264 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 Cobes Industries Co., Ltd. devices

FDA 510(k) Submission Details - K112378

510(k) Number K112378 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 18, 2011
Decision Date May 08, 2012
Days to Decision 264 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
135d slower than avg
Panel avg: 129d · This submission: 264d
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 207
Devices cleared under the same product code (KKX) and FDA review panel - the closest regulatory comparables to K112378.
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