Cleared Traditional

K111458 - GRI STERILE AND NON-STERILE SURGICAL DR...

K111458 is the FDA 510(k) clearance for GRI STERILE AND NON-STERILE SURGICAL DR... by Gri Medical & Electronic Technology Co., Ltd.. It is a Class 2 General Hospital device (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
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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
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.

Device Classification

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 146
Devices cleared under the same product code (KKX) and FDA review panel - the closest regulatory comparables to K111458.
BeneHold Surgical Incise Drape with CHG antimicrobial
K202208 · Avery Dennison Belgie Bvba · Jul 2021
ControlRad Sterile Cover
K200238 · Controlrad, Inc. · Apr 2020
SURGISLEEVE WOUND PROTECTOR
K140064 · Covidien · Mar 2014
KIMBERLY-CLARK SURGICAL DRAPES WITH AAMI LIQUID BARRIER LEVEL 4 CLAIM
K102666 · Kimberly-Clark Corp. · Nov 2010
KIMBERLY-CLARK KC100 SURGICAL DRAPES, MODEL KC 100, KIMBERLY-CLARK KC100 SURGICAL EQUIPMENT COVERS, MODEL KC 100
K083234 · Kimberly-Clark Corp. · Mar 2009
ARROW INTERNATIONAL, INC., SURGICAL DRAPES
K071491 · Arrow Intl., Inc. · Oct 2007