Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012337868

FEI Number

3012337868

Entity Name

InfuSystem Inc.

City/State/Country

Mississauga Ontario, CA

Establishment Address

5035 Timberlea Blvd, Unit 3, Mississauga Ontario L4W 2W9, CA

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198

Owner / Operator

InfuSystem Inc. (Owner Number: 10052123)

Owner / Operator Contact Address

11130 Strange Line Rd., Lenexa, KS 66215, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K031361

PMA Number

N/A

All Registered Proprietary Names

CADD SOLIS VIP AMBULATORY INFUSION PUMP AND CADD SOLIS MEDICATION SAFETY SOFTWARE MEDLEY SYRINGE PUMP MODULE SYSTEM, MODEL 8110 Medfusion 3500 Syringe Pump CADD Legacy One CUE AMBULATORY VOLUMETRIC INFUSION PUMP CADD External Power Pack Alaris PC Unit Model 8000 and 8015 Spectrum IQ Infusion System with Dose IQ Safety Software Q CORE Sapphire Pump Baxter Spectrum BD Alaris System with Guardrails Suite MX v12.1.2 CADD HIGH-VOLUME ADMINISTRATION SETS WITH FLOWSTOP

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FRN	Pump, Infusion	General Hospital	Class 2	880.5725	2024-10-25
FRN	Pump, Infusion	General Hospital	Class 2	880.5725	2024-10-25
FRN	Pump, Infusion	General Hospital	Class 2	880.5725	2016-12-06
FRN	Pump, Infusion	General Hospital	Class 2	880.5725	2021-12-21
MEA	Pump, Infusion, Pca	General Hospital	Class 2	880.5725	2016-06-16
FRN	Pump, Infusion	General Hospital	Class 2	880.5725	2024-10-25
FRN	Pump, Infusion	General Hospital	Class 2	880.5725	2016-06-16
FRN	Pump, Infusion	General Hospital	Class 2	880.5725	2024-10-25
FRN	Pump, Infusion	General Hospital	Class 2	880.5725	2024-10-25
PHC	Infusion Safety Management Software	General Hospital	Class 2	880.5725	2024-10-25
MRZ	Accessories, Pump, Infusion	General Hospital	Class 2	880.5725	2021-01-27
FRN	Pump, Infusion	General Hospital	Class 2	880.5725	2021-01-27
FRN	Pump, Infusion	General Hospital	Class 2	880.5725	2016-06-16
PHC	Infusion Safety Management Software	General Hospital	Class 2	880.5725	2016-06-16
FRN	Pump, Infusion	General Hospital	Class 2	880.5725	2016-06-16
FRN	Pump, Infusion	General Hospital	Class 2	880.5725	2016-06-16
MEA	Pump, Infusion, Pca	General Hospital	Class 2	880.5725	2024-10-25
PHC	Infusion Safety Management Software	General Hospital	Class 2	880.5725	2024-10-25
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2024-10-25
FRN	Pump, Infusion	General Hospital	Class 2	880.5725	2024-10-25
FRN	Pump, Infusion	General Hospital	Class 2	880.5725	2016-06-16
MEA	Pump, Infusion, Pca	General Hospital	Class 2	880.5725	2016-06-16
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2016-06-16
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2024-10-25

Official Correspondent

Melissa Mackey

US Agent Details

Melissa Mackey Business: InfuSystem Inc. Email: melissa.mackey@infusystem.com Phone: (913) 5298933

Related Public Records

Same Entity

InfuSystem Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3004906872	InfuSystem Inc.	Lenexa, KS, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K913718	Abbott Laboratories	PANCRETEC I.V. MODEL 5000 INFUS DEVICE, MODIFIED	1991-10-30
K840616	Advanced Bio Systems, Inc.	MINI-PUMP U-100	1984-03-30
K850183	Deltec Systems, Inc.	CADD-VT, 5300 AMBULATORY INFUSION PUMP W/3050, 50M	1985-03-13
K142467	Abeon Medical Corporation	IntelAir Nasal Airway Support System	2014-11-24
K861213	Datex Division Instrumentarium Corp.	PB 254 IR - SPECTROMETER	1986-04-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0001-2011	Baxter Healthcare Corp. Rt.	2	Baxter Colleague Single Channel Volumetric Infusion Pumps. Baxter Healthcare Corporation, Medication Delivery Division. Product Codes: 2M8151, 2M8161, and 2M9161.
Z-0002-2011	Baxter Healthcare Corp. Rt.	2	Baxter Colleague Triple Channel Volumetric Infusion Pumps. Baxter Healthcare Corporation, Medication Delivery Division. Product codes: 2M8153, and 2M8163.
Z-0005-2025	Zyno Medical LLC	2	Z-800 Infusion System, Model Numbers Z-800, Z-800F, Z-800W, Z-800WF; Software Version: Z-800 6.1.01 and 6-1.07z; Z-800F 4.1.02 and 4.1.08z; Z-800W 3.1.32 and 3.1.64z, Z-800WF 3.1.32 and 3.1.64z
Z-0006-2011	CareFusion Corporation	2	CareFusion Alaris PC Unit Model 8015 (formerly Medley PC Unit): Alaris PC Units (Model 8015) with logic board part number TC10005522 manufactured and serviced between December 20, 2008 and May 6, 2009; and Alaris PC Units (with logic board part number TC10005572 manufactured and serviced between May 7, 2009 and September 8, 2009. For use with Alaris infusion and monitoring systems.
Z-0007-2012	B Braun Medical, Inc	2	Outlook ES Safety Infusion System, Model 621-100ES, 621-200ES, 621-300ES, and 621-400ES B. Braun Medical Inc., 1601 Wallace Drive, Suite 150, Carrollton, TX 75006 The Outlook ES pump is intended for use with B. Braun Medical Inc., Horizon Pump IV Sets to regulate the flow of primary and secondary fluids when positive pressure is required.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012337868. Last updated year: 2026. Please use registration number 3012337868 when referencing this establishment in official correspondence.