Cleared Traditional

K030908 - DEROYAL SURGICAL DRAPES BACKTABLE COVER

K030908 is the FDA 510(k) clearance for DEROYAL SURGICAL DRAPES BACKTABLE COVER by Deroyal. It is a Class 2 General Hospital device (product code KKX) cleared through the Traditional 510(k) pathway after a 140-day FDA review.

K030908 · Deroyal · General Hospital
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Aug 2003
Decision
140d
Days
Class 2
Risk

K030908 is an FDA 510(k) clearance for the DEROYAL SURGICAL DRAPES BACKTABLE COVER. Classified as Drape, Surgical (product code KKX), Class II - Special Controls.

Submitted by Deroyal (Powell, US). The FDA issued a Cleared decision on August 11, 2003 after a review of 140 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.

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Submission Details

510(k) Number K030908 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 2003
Decision Date August 11, 2003
Days to Decision 140 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
11d slower than avg
Panel avg: 129d · This submission: 140d
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 K030908.
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
DEROYAL DRAPES, STERILE, NON-STERILE
K030365 · Deroyal Industries, Inc. · Apr 2003
TRILAMINATE DRAPES/TIBURON
K023419 · Allegiance Healthcare Corp. · Feb 2003
DRAPES WITH ABSORBENT REINFORCEMENT
K023425 · Allegiance Healthcare Corp. · Nov 2002