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Data / Medical devices / United States / Vantive US Healthcare LLC

Vantive US Healthcare LLC: FDA-registered device maker in Deerfield, IL, United States, 38 510(k) clearances and 1 PMA approval

Vantive US Healthcare LLC is registered with the FDA (registration 3038195011) in Deerfield, IL, United States. It lists 15 device types. The FDA files 38 510(k) clearances and 1 PMA approval under its listings, the newest dated August 1, 2025. 2 recall events name it as the recalling firm. 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 Vantive US Healthcare LLC
FDA registration number
3038195011
Address
510 Lake Cook Rd, Deerfield, IL, United States, 60015
Owner or operator
Vantive US Healthcare LLC (9038727)
Roles
Complaint file establishment, Manufacturer
First device listed
September 27, 1983
Registered through
2026
Brand names listed
12 ft Extension Set, 15L Cycler Drainage Bag, 3L Ultra Set CAPD Disposable Y-Set, AK 98 Dialysis Machine, Amia Automated PD System with Sharesource, Automated Dialysis Cycler System, Automated PD Set with Cassette 4-Prong, BICART and more

Devices it lists

DeviceProduct codeClassRoleSource
Accessories, Blood Circuit, HemodialysisKOC2Complaint file establishmentaccessdata.fda.gov
Apparatus, Hemoperfusion, SorbentFLD2Complaint file establishmentaccessdata.fda.gov
Clamp, LineFKK1Complaint file establishmentaccessdata.fda.gov
Dialysate Concentrate For Hemodialysis (Liquid Or Powder)KPO2Complaint file establishmentaccessdata.fda.gov
Dialyzer, Capillary, Hollow FiberFJI2Complaint file establishmentaccessdata.fda.gov
Dialyzer, High Permeability With Or Without Sealed Dialysate SystemKDI2Complaint file establishmentaccessdata.fda.gov
Dressing, Wound, HydrophilicNAC1Complaint file establishmentaccessdata.fda.gov
Hemodialyzer With Expanded Solute Removal ProfileQAX2Complaint file establishmentaccessdata.fda.gov
Hemodialyzer, Re-Use, High FluxMSF2Complaint file establishmentaccessdata.fda.gov
Separator For Therapeutic Purposes, Membrane Automated Blood Cell/PlasmaMDP3Complaint file establishmentaccessdata.fda.gov
Set, Administration, For Peritoneal Dialysis, DisposableKDJ2Complaint file establishmentaccessdata.fda.gov
Set, Tubing, Blood, With And Without Anti-Regurgitation ValveFJK2Complaint file establishmentaccessdata.fda.gov
Subsystem, Water PurificationFIP2Complaint file establishmentaccessdata.fda.gov
System, Hemodialysis, Remote AccessoriesMON1Complaint file establishmentaccessdata.fda.gov
System, Peritoneal, Automatic DeliveryFKX2Complaint file establishment, Manufactureraccessdata.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
August 1, 2025K250508AK 98 Dialysis Machine (955607)KDISubstantially EquivalentVantive US Healthcare, LLCaccessdata.fda.gov
March 12, 2024K231849MiniCap Extended Life PD Transfer Set with Twist Clamp - Code 5C4482A; MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Short - Code 5C4483KDJSubstantially EquivalentBaxter Healthcareaccessdata.fda.gov
September 14, 2023K232467CleanCart A, CleanCart C, AK 98 Hemodialysis MachineKDISubstantially EquivalentBaxter Healthcare Corporationaccessdata.fda.gov
April 1, 2022K212216Prismaflex ST60 Set, Prismaflex ST100 Set, Prismaflex ST150 setKDISubstantially EquivalentBaxter Healthcare Corporationaccessdata.fda.gov
March 18, 2022K21401615L Cycler Drainage BagKDJSubstantially EquivalentBaxter Healthcare Corporationaccessdata.fda.gov
January 24, 2022K213639Revaclear 500, Revaclear 400, Revaclear 300KDISubstantially EquivalentBaxter Healthcare Corporationaccessdata.fda.gov
October 19, 2021K211035U9000 Plus UltrafilterFIPSubstantially EquivalentBaxter Healthcare Corporationaccessdata.fda.gov
March 10, 2021K201809AK 98 Dialysis Machine, U9000 Ultrafilter, C705 Expansion Chamber AccessoryKDISubstantially EquivalentBaxter Healthcare Corportationaccessdata.fda.gov
November 19, 2020K201867Homechoice Claria APD System, Sharesource Connectivity Platform for Use with the Homechoice Claria APD SystemFKXSubstantially EquivalentBaxter Healthcare Corporationaccessdata.fda.gov
August 28, 2020DEN190042Theranova Dialyzers, Theranova 400 Dialyzer, Theranova 500 DialyzerQAXUnknownBaxter Healthcare Corporationaccessdata.fda.gov
March 13, 2020K193482PrisMax System Version 3KDISubstantially EquivalentBaxter Healthcare Corporationaccessdata.fda.gov
July 25, 2019K190910PrisMax System Version 2KDISubstantially EquivalentBaxter Healthcare Corpaccessdata.fda.gov
January 6, 2017K162887PrismaSATEKPOSubstantially EquivalentBaxter Healthcare Corporationaccessdata.fda.gov
October 29, 2015K152675EXTENDED LIFE CAPD TRANSFER SET, PERITONEAL DIALYSIS TITANIUM CATHETER ADAPTER AND LOCKING CAP FOR TITANIUM CATHETER ADAPTERKDJSubstantially EquivalentBaxter Healthcareaccessdata.fda.gov
October 29, 2015K152129FlexiCap Disconnect Cap with Povidone-Iodine Solution, MiniCap with Povidone-Iodine SolutionKDJSubstantially EquivalentBaxter Healthcare Corporationaccessdata.fda.gov
October 9, 2015K151525Amia Automated PD System with SharesourceFKXSubstantially EquivalentDeka Research and Developmentaccessdata.fda.gov
March 26, 2014K133807MARS MONITOR ITC US, MARS TREATMENT KIT TYPE 1116/1 - X-MARS US, PRISMAFLEX CONTROL UNITFLDSubstantially EquivalentGambro Renal Products, Inc.accessdata.fda.gov
May 2, 2013K130039REVACLEAR 300 DIALYZER, REVACLEAR 400 DIALYZERKDISubstantially EquivalentGambro Renal Products, Inc.accessdata.fda.gov
December 14, 2012K113313MOLECULAR ADSORBENT RECIRCULATING(MARS)FLDSubstantially EquivalentGambro Renal Products, Inc.accessdata.fda.gov
March 30, 2011K102936HOMECHOICE/HOMECHOICE PRO AUTOMATED PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM MODEL 5C4471, 5C8310, 5C4471R AND 5C8310RFKXSubstantially EquivalentBaxter Healthcare Corpaccessdata.fda.gov
November 3, 2010K100364GAMBRO CARTRIDGE BLOOD SET LOW WEIGHT- LOW VOLUME, MODEL 003422-520FJKSubstantially EquivalentGambro Renal Products, Inc.accessdata.fda.gov
June 13, 2008K080519PRISMAFLEX M150 SETKDISubstantially EquivalentGambro Renal Products, Inc.accessdata.fda.gov
February 4, 2008K072908PRISMASATE DIALYSIS SOLUTIONS FOR CONTINUOUS RENAL REPLACEMENT THERAPYKPOSubstantially EquivalentGambro Renal Productsaccessdata.fda.gov
October 12, 2007K070414GAMBRO CARTRIDGE BLOOD SETSFJKSubstantially EquivalentGambro Renal Productsaccessdata.fda.gov
December 9, 2005K051520GAMBRO POLYFLUX HEMODIALYZER, MODEL 6HKDISubstantially EquivalentGambro Renal Productsaccessdata.fda.gov
May 27, 2005K043342POLYFLUX FAMILY HEMODIALYZER/FILTER LABELED FOR SINGLE AND MULTIPLE USE, MODELS 14L, 17L, 21L, 140H, 170H, 210H,6LR, 8LRFJISubstantially EquivalentGambro Renal Productsaccessdata.fda.gov
January 6, 2005K042938GAMBRO PRISMAFLEX HF1000 AND HF1400 SETSKDISubstantially EquivalentGambro Renal Productsaccessdata.fda.gov
October 7, 2004K041005GAMBRO PRISMAFLEX AND GAMBRO PRISMAFLEX M60 & M100 SETSKDISubstantially EquivalentGambro Renal Productsaccessdata.fda.gov
January 8, 2002K013724BICARTKPOSubstantially EquivalentGambro Renal Productsaccessdata.fda.gov
December 5, 2001K012988HOMECHOICE PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM, MODELS 5C8310, 5C8302, 5C4471, 5C4469FKXSubstantially EquivalentBaxter Healthcare Corpaccessdata.fda.gov
November 1, 2001K003957DIACLEAR ULTRAFILTERFIPSubstantially EquivalentGambro Renal Productsaccessdata.fda.gov
August 6, 1996K961825ULTRASET/3L CAPD DISPOSABLE DISCONNECT Y-SET MODELS 5C4366 & 5C4493KDJSubstantially EquivalentBaxter Healthcare Corpaccessdata.fda.gov
March 4, 1994K923065BAXTER PERSONAL CYCLER AUTOMMATED PERITONEAL DIALFKXSubstantially EquivalentBaxter Healthcare Corpaccessdata.fda.gov
February 22, 1994K925403BAXTER APD 12' EXTENSION LINEKDJSubstantially EquivalentBaxter Healthcare Corpaccessdata.fda.gov
November 28, 1983K833065AUTOMATIC PERITONEAL DIALYSIS CYCLERFKXSubstantially EquivalentTravenol Laboratories, S.A.accessdata.fda.gov
January 5, 1983K823707HOSPAL BLOOD LINESKOCSubstantially EquivalentHospal Medical Corp.accessdata.fda.gov
May 30, 1980K801016GAMBRO G SERIES BLOOD LINE SETS FOR HEM.FJKSubstantially EquivalentGambro, Inc.accessdata.fda.gov
November 13, 1979K791899CYCLER SETS MOD. #5C4143, 5C4144, 5C4145KDJSubstantially EquivalentTravenol Laboratories, S.A.accessdata.fda.gov

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

ApprovedPMA numberDeviceProduct codeSupplementsLatest decisionSource
May 27, 1986P830063GAMBRO FIBER PLASMAFILTERMDP30July 15, 2026accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

InitiatedEventClassStatusProductReasonSource
January 6, 202698180Class IIOngoingPRISMAFLEX ST100 SET US, Product Code 107636US; Dialyzer, High Permeability With Or Without Sealed Dialysate SystemThere is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.accessdata.fda.gov
July 28, 202597233Class IIOngoingPrisMax V2-US, Hemodialysis Delivery System, Product Codes: 955626, 955558, 955627, 955701Low deaeration chamber level at post priming tests may lead to PrisMax System alarm T2309: Air Detected in Prime resulting in multiple additional priming cyclesaccessdata.fda.gov

Compare with other makers

Updated July 15, 2026. 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.