Cleared Traditional

K111458 - GRI STERILE AND NON-STERILE SURGICAL DRAPES AND SURGICAL EQUIPMENT COVERS

K111458 is an FDA 510(k) clearance for GRI STERILE AND NON-STERILE SURGICAL DR..., manufactured by Gri Medical & Electronic Technology Co., Ltd.. The device is a Class 2 General Hospital device with product code KKX cleared through the Traditional 510(k) pathway after a 189-day FDA review.

K111458 · Gri Medical & Electronic Technology Co., Ltd. · General Hospital
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Dec 2011
Decision
189d
Days
Class 2
Risk

K111458 is an FDA 510(k) clearance for the GRI STERILE AND NON-STERILE SURGICAL DRAPES AND SURGICAL EQUIPMENT COVERS. Classified as Drape, Surgical (product code KKX), Class II - Special Controls.

Submitted by Gri Medical & Electronic Technology Co., Ltd. (Swanee, US). The FDA issued a Cleared decision on December 1, 2011 after a review of 189 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 Gri Medical & Electronic Technology Co., Ltd. devices

FDA 510(k) Submission Details - K111458

510(k) Number K111458 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 26, 2011
Decision Date December 01, 2011
Days to Decision 189 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
60d slower than avg
Panel avg: 129d · This submission: 189d
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 262
Devices cleared under the same product code (KKX) and FDA review panel - the closest regulatory comparables to K111458.
SURGICAL DRAPE WITH AAMI LIQUID BARRIER LEVEL IV
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COBES SURGICAL DRAPE
K112378 · Cobes Industries Co., Ltd. · May 2012
TOP DRAPE STERILE, TOP DRAPE-NON STERILE, BOTTOM DRAPE- STERILE, BOTTOM DRAPE
K112136 · Kunshan Jiehong Nonwoven Product Co., Ltd. · Sep 2011
KIMBERLY-CLARK SURGICAL DRAPES WITH AAMI LIQUID BARRIER LEVEL 4 CLAIM
K102666 · Kimberly-Clark Corp. · Nov 2010
BUSSE SURGICAL DRAPES IV
K093909 · Busse Hospital Disposables, Inc. · May 2010