Cleared Special

K091386 - MICROFUSE DUAL RATE INFUSER

K091386 is an FDA 510(k) clearance for MICROFUSE DUAL RATE INFUSER, manufactured by Numia Medical Technology, LLC. The device is a Class 2 General Hospital device with product code FRN cleared through the Special 510(k) pathway after a 144-day FDA review.

K091386 · Numia Medical Technology, LLC · General Hospital
Download Printable Device Report (PDF)
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Oct 2009
Decision
144d
Days
Class 2
Risk

K091386 is an FDA 510(k) clearance for the MICROFUSE DUAL RATE INFUSER. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Numia Medical Technology, LLC (Lyndonville, US). The FDA issued a Cleared decision on October 2, 2009 after a review of 144 days - within the typical 510(k) review window.

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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Numia Medical Technology, LLC devices

FDA 510(k) Submission Details - K091386

510(k) Number K091386 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 11, 2009
Decision Date October 02, 2009
Days to Decision 144 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
15d slower than avg
Panel avg: 129d · This submission: 144d
Pathway characteristics
Modification to existing cleared device.

FRN Device Classification - Class 2, Special Controls

Product Code FRN Pump, Infusion
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 - FRN Pump, Infusion

All 534
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K091386.
MEDFUSION MODEL 4000 SYRINGE INFUSION PUMP, PHARMGUARD TOOLBOX 2 MEDICATION SAFETY SOFTWARE AND SUPPORTED SYRINGES (PSS)
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MEDRAD INTEGO PET INFUSION SYSTEM, SOURCE ADMINISTRATION SET, PATIENT ADMINSTRATIN SET MODEL INT SYS 100, INT CSS, INT C
K100798 · Medrad, Inc. · Jun 2010
SYNERGETICS ADJUSTABLE GAS PRESSURIZED INFUSION (AGPI) TUBE SET
K091441 · Synergetics, Inc. · Oct 2009
INFUSOMAT SPACE VOLUMETRIC INFUSION PUMP SYSTEM
K083689 · B.Braun Medical, Inc. · Jul 2009
THE BELMONT FLUID MANAGEMENT SYSTEM/ THE BELMONT RAPID INFUSER, MODEL FMS2000
K091855 · Belmont Instrument Corp. · Jul 2009
POWER INFUSER, MODEL M100B-3A
K090736 · ZOLL Medical Corporation · May 2009