Cleared Traditional

K041846 - SABRESOURCE DRAPE

K041846 is an FDA 510(k) clearance for SABRESOURCE DRAPE, manufactured by Minrad, Inc.. The device is a Class 2 General Hospital device with product code KKX cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K041846 · Minrad, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2004
Decision
49d
Days
Class 2
Risk

K041846 is an FDA 510(k) clearance for the SABRESOURCE DRAPE. Classified as Drape, Surgical (product code KKX), Class II - Special Controls.

Submitted by Minrad, Inc. (Buffalo, US). The FDA issued a Cleared decision on August 26, 2004 after a review of 49 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Minrad, Inc. devices

FDA 510(k) Submission Details - K041846

510(k) Number K041846 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 08, 2004
Decision Date August 26, 2004
Days to Decision 49 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
80d faster than avg
Panel avg: 129d · This submission: 49d
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 165
Devices cleared under the same product code (KKX) and FDA review panel - the closest regulatory comparables to K041846.
GORE-TEX NON-STERILE SURGICAL GOWNS
K052833 · Medline Industries, Inc. · Feb 2006
STERILE EQUIPMENT COVERS
K052395 · Volcano Corporation · Dec 2005
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