Cleared Traditional

K053495 - EQUIPMENT SLUSH DRAPE

K053495 is an FDA 510(k) clearance for EQUIPMENT SLUSH DRAPE, manufactured by Advance Medical Designs, Inc.. The device is a Class 2 General Hospital device with product code KKX cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K053495 · Advance Medical Designs, Inc. · General Hospital
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Mar 2006
Decision
91d
Days
Class 2
Risk

K053495 is an FDA 510(k) clearance for the EQUIPMENT SLUSH DRAPE. Classified as Drape, Surgical (product code KKX), Class II - Special Controls.

Submitted by Advance Medical Designs, Inc. (Marietta, US). The FDA issued a Cleared decision on March 16, 2006 after a review of 91 days - within the typical 510(k) review window.

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 Advance Medical Designs, Inc. devices

FDA 510(k) Submission Details - K053495

510(k) Number K053495 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 15, 2005
Decision Date March 16, 2006
Days to Decision 91 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
38d faster than avg
Panel avg: 129d · This submission: 91d
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 K053495.
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
GORE-TEX NON-STERILE SURGICAL GOWNS
K052833 · Medline Industries, Inc. · Feb 2006
STERILE EQUIPMENT COVERS
K052395 · Volcano Corporation · Dec 2005
3L SURGICAL DRAPES
K043015 · 3l Medical Products Co., Ltd. · Aug 2005