Cleared Special

K090300 - MODIFICATION TO AUTOFUSER

K090300 is an FDA 510(k) clearance for MODIFICATION TO AUTOFUSER, manufactured by Ace Medical Us, LLC. The device is a Class 2 General Hospital device with product code MEB cleared through the Special 510(k) pathway after a 83-day FDA review.

K090300 · Ace Medical Us, LLC · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2009
Decision
83d
Days
Class 2
Risk

K090300 is an FDA 510(k) clearance for the MODIFICATION TO AUTOFUSER. Classified as Pump, Infusion, Elastomeric (product code MEB), Class II - Special Controls.

Submitted by Ace Medical Us, LLC (Powell, US). The FDA issued a Cleared decision on April 30, 2009 after a review of 83 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.

FDA 510(k) Submission Details - K090300

510(k) Number K090300 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 06, 2009
Decision Date April 30, 2009
Days to Decision 83 days
Submission Type Special
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
46d faster than avg
Panel avg: 129d · This submission: 83d
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 87
Devices cleared under the same product code (MEB) and FDA review panel - the closest regulatory comparables to K090300.
SMARTez elastomeric infusion pump
K151650 · Epic Medical Pte. , Ltd. · Apr 2016
ON-Q PAINBUSTER, ON-Q C-BLOC, HOMEPUMP ECLIPSE, HOMEPUMP C-SERIES
K131249 · I-Flow, LLC · Feb 2014
MULTIBOLUS II DISPOSABLE PAIN MANAGEMENT SYSTEM
K131247 · Mfs - Medical Flow Systems, Ltd. · Aug 2013
ACCUFLOW AND ACCUFLUX ELASTOMERIC INFUSION PUMP
K081905 · Westmed, Inc. · Jul 2008
ALPHA INFUSION PUMP, MODEL A200, A450
K071532 · Advanced Infusion, Inc. · Feb 2008
DISPOSABLE INFUSION PUMP KIT, GO PUMP RAPID RECOVERY SYSTEM
K072921 · Symbios Medical Products, LLC · Nov 2007
K090300 · MODIFICATION TO AUTOFUSER
Download PDF FDA Summary Ace Medical Us, LLC