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Data / Medical devices / Canada / InfuSystem Inc.

InfuSystem Inc.: FDA-registered device maker in Mississauga Ontario, Canada, 21 510(k) clearances

InfuSystem Inc. is registered with the FDA (registration 3012337868) in Mississauga Ontario, Canada. It lists 8 device types. The FDA files 21 510(k) clearances under its listings, the newest dated July 21, 2023. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this oneWatch InfuSystem Inc.
FDA registration number
3012337868
Address
5035 Timberlea Blvd Unit 3, Mississauga Ontario, Canada, L4W 2W9
Owner or operator
InfuSystem Inc. (10052123)
Roles
Complaint file establishment
First device listed
June 16, 2016
Registered through
2026
Brand names listed
Alaris PC Unit Model 8000 and 8015, BD Alaris System with Guardrails Suite MX v12.1.2, Baxter Spectrum, CADD ADMINISTRATION SET WITH FLOW STOP, MEDICATION CASSETTE RESERVOIR WITH FLOW STOP AND EXTENSION SET, CADD External Power Pack, CADD HIGH-VOLUME ADMINISTRATION SETS WITH FLOWSTOP, CADD Legacy One, CADD SOLIS VIP AMBULATORY INFUSION PUMP AND CADD SOLIS MEDICATION SAFETY SOFTWARE and more

Devices it lists

DeviceProduct codeClassRoleSource
Accessories, Pump, InfusionMRZ2Complaint file establishmentaccessdata.fda.gov
Analyzer, Gas, Carbon-Dioxide, Gaseous-PhaseCCK2Complaint file establishmentaccessdata.fda.gov
Infusion Safety Management SoftwarePHC2Complaint file establishmentaccessdata.fda.gov
OximeterDQA2Complaint file establishmentaccessdata.fda.gov
Pump, InfusionFRN2Complaint file establishmentaccessdata.fda.gov
Pump, Infusion, EnteralLZH2Complaint file establishmentaccessdata.fda.gov
Pump, Infusion, PcaMEA2Complaint file establishmentaccessdata.fda.gov
Set, Administration, IntravascularFPA2Complaint file establishmentaccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
July 21, 2023K211218BD Alaris System with Guardrails Suite MX v12.1.2FRNSubstantially EquivalentCarefusion 303, Inc.accessdata.fda.gov
September 6, 2022K222048Spectrum IQ Infusion System with Dose IQ Safety SoftwareFRNSubstantially EquivalentBaxter Healthcare Corporationaccessdata.fda.gov
March 27, 2017K161667Sapphire Infusion PumpFRNSubstantially EquivalentQ Core Medical , Ltd.accessdata.fda.gov
May 7, 2014K133801BAXTER SIGMA SPECTRUM INFUSION PUMP WITH MASTER DRUG LIBRARYFRNSubstantially EquivalentBaxter Healthcare Corporationaccessdata.fda.gov
February 1, 2013K111275CADD SOLIS VIP AMBULATORY INFUSION PUMP AND CADD SOLIS MEDICATION SAFETY SOFTWAREFRNSubstantially EquivalentSmiths Medical Asd, Inc.accessdata.fda.gov
November 4, 2009K092313PERFUSOR SPACE INFUSION SYRINGE PUMP SYSTEMMEASubstantially EquivalentB.Braun Medical, Inc.accessdata.fda.gov
July 9, 2009K091308ALARIS PC UNIT, MODELS 8000 AND 8015FRNSubstantially EquivalentCardinal Health 303,Inc.accessdata.fda.gov
July 1, 2009K083689INFUSOMAT SPACE VOLUMETRIC INFUSION PUMP SYSTEMFRNSubstantially EquivalentB.Braun Medical, Inc.accessdata.fda.gov
May 12, 2006K060479MODIFICATION TO BODYGUARD INFUSION PUMP SYSTEMFRNSubstantially EquivalentCaesarea Medical Electronics , Ltd.accessdata.fda.gov
March 11, 2005K042696BODYGUARD INFUSION PUMP SYSTEMFRNSubstantially EquivalentCaesarea Medical Electronics , Ltd.accessdata.fda.gov
May 19, 2004K040636CADD ADMINISTRATION SET WITH FLOW STOP, MEDICATION CASSETTE RESERVOIR WITH FLOW STOP AND EXTENSION SETFPASubstantially EquivalentSmiths Medical MD, Inc.accessdata.fda.gov
July 9, 2003K031199ENTERALITE INFINITY ENTERAL FEEDING PUMPLZHSubstantially EquivalentZevex Intl., Inc.accessdata.fda.gov
May 23, 2003K031361CADD HIGH-VOLUME ADMINISTRATION SETS WITH FLOWSTOPFPASubstantially EquivalentDeltec, Inc.accessdata.fda.gov
December 19, 2002K023264MEDLEY SYRINGE PUMP MODULE SYSTEM, MODEL 8110FRNSubstantially EquivalentAlaris Medical Systems, Inc.accessdata.fda.gov
December 4, 1998K981816CUE AMBULATORY VOLUMETRIC INFUSION PUMPFRNSubstantially EquivalentBecton Dickinson Curlin, LLCaccessdata.fda.gov
November 4, 1998K982838CADD-LEGACY 1 AMBULATORY INFUSION SYSTEM MODEL NUMBER 6400FRNSubstantially EquivalentSims Deltec, Inc.accessdata.fda.gov
November 2, 1998K982839CADD-LEGACY PCA AMBULATORY INFUSION SYSTEM, MODEL 6300MEASubstantially EquivalentSims Deltec, Inc.accessdata.fda.gov
November 2, 1998K982836CADD-LEGACY PLUS AMBULATORY INFUSION SYSTEMFRNSubstantially EquivalentSims Deltec, Inc.accessdata.fda.gov
August 23, 1996K960826CADD-PRIZM MODEL 6100 PUMPFRNSubstantially EquivalentSims Deltec, Inc.accessdata.fda.gov
June 4, 1996K960957EXTERNAL POWER SOURCE (EPS) SYSTEM, POWER PACKFRNSubstantially EquivalentSims Deltec, Inc.accessdata.fda.gov
July 27, 1989K890120SYRINGE INFUSION PUMPFRNSubstantially EquivalentMedfusion, Inc.accessdata.fda.gov

Compare with other makers

Updated July 21, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.