Cleared Traditional

K052395 - STERILE EQUIPMENT COVERS

K052395 is the FDA 510(k) clearance for STERILE EQUIPMENT COVERS by Volcano Corporation. It is a Class 2 General Hospital device (product code KKX) cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K052395 · Volcano Corporation · General Hospital
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Dec 2005
Decision
92d
Days
Class 2
Risk

K052395 is an FDA 510(k) clearance for the STERILE EQUIPMENT COVERS. Classified as Drape, Surgical (product code KKX), Class II - Special Controls.

Submitted by Volcano Corporation (Rancho Cordova,, US). The FDA issued a Cleared decision on December 1, 2005 after a review of 92 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 Volcano Corporation devices

Submission Details

510(k) Number K052395 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 2005
Decision Date December 01, 2005
Days to Decision 92 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
37d faster than avg
Panel avg: 129d · This submission: 92d
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 145
Devices cleared under the same product code (KKX) and FDA review panel - the closest regulatory comparables to K052395.
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
GORE-TEX NON-STERILE SURGICAL GOWNS
K052833 · Medline Industries, Inc. · Feb 2006
MEDLINE STERILE DISPOSABLE SURGICAL GOWNS/DRAPES
K032666 · Medline Industries, Inc. · Mar 2005
ALEXIS WOUND RETRACTOR
K031889 · Applied Medical Resources Corp. · Sep 2003
STERI-DRAPE SURGICAL DRAPES
K031287 · 3M Company · Sep 2003