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Data / Medical devices / United States / InfuSystem Inc.

InfuSystem Inc.: FDA-registered device maker in Lenexa, KS, United States, 26 510(k) clearances

InfuSystem Inc. is registered with the FDA (registration 3004906872) in Lenexa, KS, United States. It lists 18 device types. The FDA files 26 510(k) clearances under its listings, the newest dated January 23, 2024. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch InfuSystem Inc.
FDA registration number
3004906872
Address
11130 Strang Line Rd., Lenexa, KS, United States, 66215
Owner or operator
InfuSystem Inc. (10029405)
Roles
Complaint file establishment
First device listed
June 30, 2015
Registered through
2026
Brand names listed
500 ML Bag Enteralite Infinity Set, Alaris 8015, Alaris 8110, Baxter Sigma Spectrum Infusion Pump with Master Drug Library, CADD Administration Set, CADD Extension Set, CADD High Volume Admin Set, CADD Legacy One and more

Devices it lists

DeviceProduct codeClassRoleSource
Accessories, Pump, InfusionMRZ2Complaint file establishmentaccessdata.fda.gov
Aid, Cardiopulmonary ResuscitationLIX2Complaint file establishmentaccessdata.fda.gov
Analyzer, Gas, Carbon-Dioxide, Gaseous-PhaseCCK2Complaint file establishmentaccessdata.fda.gov
Automated External Defibrillators (Non-Wearable)MKJ3Complaint file establishmentaccessdata.fda.gov
Dc-Defibrillator, Low-Energy, (Including Paddles)LDD2Complaint file establishmentaccessdata.fda.gov
ElectrocardiographDPS2Complaint file establishmentaccessdata.fda.gov
Gastrointestinal Tubes With Enteral Specific ConnectorsPIF2Complaint file establishmentaccessdata.fda.gov
Infusion Safety Management SoftwarePHC2Complaint file establishmentaccessdata.fda.gov
Intraoral Cooling DeviceQUA2Complaint file establishmentaccessdata.fda.gov
Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)MWI2Complaint file establishmentaccessdata.fda.gov
OximeterDQA2Complaint file establishmentaccessdata.fda.gov
Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)DRO2Complaint 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
System, Measurement, Blood-Pressure, Non-InvasiveDXN2Complaint file establishmentaccessdata.fda.gov
System, Network And Communication, Physiological MonitorsMSX2Complaint 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
January 23, 2024K232917Chemo MouthpieceQUASubstantially EquivalentChemo Mouthpiece, LLCaccessdata.fda.gov
March 27, 2017K161667Sapphire Infusion PumpFRNSubstantially EquivalentQ Core Medical , Ltd.accessdata.fda.gov
January 8, 2015K142539EnteraLite Infinity Enteral Pump Delivery Set, 1200 mL Enteral Feeding Delivery SetPIFSubstantially EquivalentZevex, Inc.accessdata.fda.gov
May 7, 2014K133801BAXTER SIGMA SPECTRUM INFUSION PUMP WITH MASTER DRUG LIBRARYFRNSubstantially EquivalentBaxter Healthcare Corporationaccessdata.fda.gov
February 12, 2014K131154ENTERALITE INFINITY SPIKE ENTERAL DELIVERY SET; ENTERALITE INFINITY 500 ML BAG ENTERAL DELIVERY SET;LZHSubstantially EquivalentZevex, Inc.accessdata.fda.gov
December 9, 2013K130394CADD -SOLIS AMBULATORY INFUSION PUMP, VERSION 3.0MEASubstantially 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
November 22, 2006K062233HEARTSTART MRX MONITOR/DEFIBRILLATORMKJSubstantially EquivalentPhilips Medical Systems North America, Inc.accessdata.fda.gov
August 26, 2004K042121SPECTRUM AND SPECTRUM WITH MASTER DRUG LIBRARYFRNSubstantially EquivalentSigma Intl.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
March 20, 2003K023189VISTA BASIC WITH FM SYSTEMFRNSubstantially EquivalentB.Braun Medical, Inc.accessdata.fda.gov
December 19, 2002K023264MEDLEY SYRINGE PUMP MODULE SYSTEM, MODEL 8110FRNSubstantially EquivalentAlaris Medical Systems, Inc.accessdata.fda.gov
June 8, 2000K000842CADD-PRIZM PCS II MODEL 6101 AMBULATORY INFUSION SYSTEMFRNSubstantially EquivalentSims Deltec, Inc.accessdata.fda.gov
June 15, 1999K991599CADD ADMINISTRATION SETFPASubstantially EquivalentSims Deltec, 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
June 29, 1994K941445EXTENSION SET WITH ANTI-SIPHON VALVEFPASubstantially EquivalentPharmacia Deltec, Inc.accessdata.fda.gov
July 27, 1989K890120SYRINGE INFUSION PUMPFRNSubstantially EquivalentMedfusion, Inc.accessdata.fda.gov

Compare with other makers

Updated January 23, 2024. 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.