Cleared Special

K033039 - MODIFICATION TO: ACCUFUSER, ACCUFUSER PLUS, STANDARD PROCEDURE KITS

K033039 is an FDA 510(k) clearance for MODIFICATION TO: ACCUFUSER, manufactured by Mckinley, Inc.. The device is a Class 2 General Hospital device with product code MEB cleared through the Special 510(k) pathway after a 8-day FDA review.

K033039 · Mckinley, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2003
Decision
8d
Days
Class 2
Risk

K033039 is an FDA 510(k) clearance for the MODIFICATION TO: ACCUFUSER, ACCUFUSER PLUS, STANDARD PROCEDURE KITS. Classified as Pump, Infusion, Elastomeric (product code MEB), Class II - Special Controls.

Submitted by Mckinley, Inc. (Wheat Ridge, US). The FDA issued a Cleared decision on October 7, 2003 after a review of 8 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5725 - 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 Mckinley, Inc. devices

FDA 510(k) Submission Details - K033039

510(k) Number K033039 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2003
Decision Date October 07, 2003
Days to Decision 8 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
121d faster than avg
Panel avg: 129d · This submission: 8d
Pathway characteristics
Modification to existing cleared device.

MEB Device Classification - Class 2, Special Controls

Product Code MEB Pump, Infusion, Elastomeric
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5725
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 - MEB Pump, Infusion, Elastomeric

All 43
Devices cleared under the same product code (MEB) and FDA review panel - the closest regulatory comparables to K033039.
NIPRO SUREFUSER AMBULATORY INFUSION PUMP
K051828 · Nipro Medical Corporation · Dec 2005
I-FLOW ELASTOMERIC PUMP (ON-Q, PAINBUSTER, C-BLOCK, HOMEPUMP, EASYPUMP)
K052117 · I-Flow Corp. · Sep 2005
I-FLOW ELASTOMERIC PUMP (ON-Q, PAINBUSTER, C-BLOC, HOMEPUMP)
K040337 · I-Flow Corp. · May 2004
B. BRAUN NERVE BLOCK CATHETER
K030830 · B.Braun Medical, Inc. · Jul 2003
HOMEPUMP, ECLIPSE, C-SERIES, PAINBUSTER, C-BLOC, ON-Q, EASYPUMP, KVO
K023883 · I-Flow Corp. · Dec 2002
I-FLOW ELASTOMERIC PUMP WITH BOLUS
K023318 · I-Flow Corp. · Oct 2002