Cleared Traditional

K052668 - OR SPECIFIC BIG CASE BACK TABLE COVER

K052668 is an FDA 510(k) clearance for OR SPECIFIC BIG CASE BACK TABLE COVER, manufactured by Or Specific, Inc.. The device is a Class 2 General Hospital device with product code KKX cleared through the Traditional 510(k) pathway after a 300-day FDA review.

K052668 · Or Specific, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2006
Decision
300d
Days
Class 2
Risk

K052668 is an FDA 510(k) clearance for the OR SPECIFIC BIG CASE BACK TABLE COVER. Classified as Drape, Surgical (product code KKX), Class II - Special Controls.

Submitted by Or Specific, Inc. (Orlando, US). The FDA issued a Cleared decision on July 24, 2006 after a review of 300 days - an unusually long review period, suggesting complex equivalence evaluation.

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 Or Specific, Inc. devices

FDA 510(k) Submission Details - K052668

510(k) Number K052668 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 2005
Decision Date July 24, 2006
Days to Decision 300 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
171d slower than avg
Panel avg: 129d · This submission: 300d
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 239
Devices cleared under the same product code (KKX) and FDA review panel - the closest regulatory comparables to K052668.
BUSSE SURGICAL DRAPE
K082297 · Busse Hospital Disposables, Inc. · Dec 2008
ARROW INTERNATIONAL, INC., SURGICAL DRAPES
K071491 · Arrow Intl., Inc. · Oct 2007
TIBURON DRAPE, MODEL 9349N/ OPTIMA DRAPE, MODEL 9446N
K061762 · Cardinal Health, Inc. · Aug 2006
MICROTEK MEDICAL WARMING DRAPE
K060200 · Microtek Medical, Inc. · May 2006
EQUIPMENT SLUSH DRAPE
K053495 · Advance Medical Designs, Inc. · Mar 2006
GORE-TEX NON-STERILE SURGICAL GOWNS
K052833 · Medline Industries, Inc. · Feb 2006