Cleared Traditional

K071491 - ARROW INTERNATIONAL

K071491 is an FDA 510(k) clearance for ARROW INTERNATIONAL, manufactured by Arrow Intl., Inc.. The device is a Class 2 General Hospital device with product code KKX cleared through the Traditional 510(k) pathway after a 133-day FDA review.

K071491 · Arrow Intl., Inc. · General Hospital
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Oct 2007
Decision
133d
Days
Class 2
Risk

K071491 is an FDA 510(k) clearance for the ARROW INTERNATIONAL, INC., SURGICAL DRAPES. Classified as Drape, Surgical (product code KKX), Class II - Special Controls.

Submitted by Arrow Intl., Inc. (Reading, US). The FDA issued a Cleared decision on October 10, 2007 after a review of 133 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 Arrow Intl., Inc. devices

FDA 510(k) Submission Details - K071491

510(k) Number K071491 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 30, 2007
Decision Date October 10, 2007
Days to Decision 133 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
4d slower than avg
Panel avg: 129d · This submission: 133d
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 164
Devices cleared under the same product code (KKX) and FDA review panel - the closest regulatory comparables to K071491.
BUSSE SURGICAL DRAPES III
K092212 · Busse Hospital Disposables, Inc. · Oct 2009
KIMBERLY-CLARK KC100 SURGICAL DRAPES, MODEL KC 100, KIMBERLY-CLARK KC100 SURGICAL EQUIPMENT COVERS, MODEL KC 100
K083234 · Kimberly-Clark Corp. · Mar 2009
BUSSE SURGICAL DRAPE
K082297 · Busse Hospital Disposables, Inc. · Dec 2008
EQUIPMENT SLUSH DRAPE
K053495 · Advance Medical Designs, Inc. · Mar 2006
GORE-TEX NON-STERILE SURGICAL GOWNS
K052833 · Medline Industries, Inc. · Feb 2006
STERILE EQUIPMENT COVERS
K052395 · Volcano Corporation · Dec 2005