Cleared Traditional

K140195 - SURGICAL DRAPE

K140195 is an FDA 510(k) clearance for SURGICAL DRAPE, manufactured by Griffith-Lucas, LLC. The device is a Class 2 General Hospital device with product code KKX cleared through the Traditional 510(k) pathway after a 226-day FDA review.

K140195 · Griffith-Lucas, LLC · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2014
Decision
226d
Days
Class 2
Risk

K140195 is an FDA 510(k) clearance for the SURGICAL DRAPE. Classified as Drape, Surgical (product code KKX), Class II - Special Controls.

Submitted by Griffith-Lucas, LLC (Guangzhou, Guangdong, CN). The FDA issued a Cleared decision on September 10, 2014 after a review of 226 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 Griffith-Lucas, LLC devices

FDA 510(k) Submission Details - K140195

510(k) Number K140195 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 2014
Decision Date September 10, 2014
Days to Decision 226 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
97d slower than avg
Panel avg: 129d · This submission: 226d
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 K140195.
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SURGISLEEVE WOUND PROTECTOR
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