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) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

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
Combination Product No
PCCP Authorized No
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 728
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K091386.
ACCU-CHEK FLEXLINK PLUS INFUSION SET, ACCU-CHECK LINKASSIST PLUS INSERTION DEVICE
K100704 · Disetronic Medical Systems AG · May 2010
DELPHI INFUSION PUMP/ DELPHI ADMINISTRATION SET MODEL IV-01000/ MODEL IV-02XXXX (WHERE X IS ANY NUMBER BETWEEN 0-9)
K093332 · Delphi Medical Systems · Dec 2009
SYNERGETICS ADJUSTABLE GAS PRESSURIZED INFUSION (AGPI) TUBE SET
K091441 · Synergetics, Inc. · Oct 2009
ALARIS PC UNIT, MODELS 8000 AND 8015
K091308 · Cardinal Health 303,Inc. · Jul 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
K091386 · MICROFUSE DUAL RATE INFUSER
Download PDF FDA Summary Numia Medical Technol…