Cleared Special

SURGICAL DRAPES (K002419) - FDA 510(k) Clearance

Class II General Hospital device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K002419 · Allegiance Healthcare Coporation · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2000
Decision
7d
Days
Class 2
Risk

K002419 is an FDA 510(k) clearance for the SURGICAL DRAPES. Classified as Drape, Surgical (product code KKX), Class II - Special Controls.

Submitted by Allegiance Healthcare Coporation (Mcgaw Park, US). The FDA issued a Cleared decision on August 15, 2000 after a review of 7 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.4370 - the FDA general hospital device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Allegiance Healthcare Coporation devices

Submission Details

510(k) Number K002419 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 2000
Decision Date August 15, 2000
Days to Decision 7 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
122d faster than avg
Panel avg: 129d · This submission: 7d
Pathway characteristics
Modification to existing cleared device.

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 24
Devices cleared under the same product code (KKX) and FDA review panel - the closest regulatory comparables to K002419.
MEDLINE STERILE DISPOSABLE SURGICAL GOWNS/DRAPES
K032666 · Medline Industries, Inc. · Mar 2005
STERI-DRAPE SURGICAL DRAPES
K031287 · 3M Company · Sep 2003
MEDLINE ASEP PLUS SURGICAL DRAPES
K023432 · Medline Industries, Inc. · Nov 2002
ACUCAM INTRAORAL CAMERA SHEATHS, MODELS 023545, 601111, 300407, 601285
K994211 · Dentsply Intl. · Feb 2000
MEDLINE DISPOSABLE SURGICAL DRAPES AND GOWNS
K964142 · Medline Industries, Inc. · Feb 1997
STERILE AND NON-STERILE O.R. TOWELS, STERILE AND NON-STERILE X-RAY DETECTABLE O.R. TOWELS, SINGLE USE
K962205 · Medline Industries, Inc. · Nov 1996