Baxter Healthcare Corporation
Cleveland, MS, US
BAXTER HEALTHCARE CORPORATION appears in FDA device records in Cleveland, MS. FDA records list 570 510(k) clearances between and , 196 PMA records and 13 registered establishments. As of , FDA records show 768 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
5 namesFDA records resolved to Baxter Healthcare Corporation carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Baxter Biosciencerecall
- Baxter Healthcare Services L.P.recall
- Sigmarecall
- Sigma International General Medical Apparatus, Llcrecall
- Vantive US Healthcare LLCregistration, 510(k), PMA, enforcement report, recall
510(k) clearance history
Showing 50 of 570FDA records hold 570 510(k) clearances for Baxter Healthcare Corporation between 1977 and 2025. The busiest year on record is 1990, with 66. The most recent is 2025, with 6.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1977 | 1 |
| 1978 | 1 |
| 1979 | 2 |
| 1980 | 1 |
| 1981 | 2 |
| 1982 | 3 |
| 1983 | 1 |
| 1985 | 3 |
| 1986 | 1 |
| 1987 | 11 |
| 1988 | 63 |
| 1989 | 59 |
| 1990 | 66 |
| 1991 | 63 |
| 1992 | 18 |
| 1993 | 29 |
| 1994 | 30 |
| 1995 | 27 |
| 1996 | 18 |
| 1997 | 17 |
| 1998 | 15 |
| 1999 | 7 |
| 2000 | 16 |
| 2001 | 5 |
| 2002 | 6 |
| 2003 | 7 |
| 2004 | 6 |
| 2005 | 3 |
| 2006 | 6 |
| 2007 | 4 |
| 2008 | 4 |
| 2009 | 4 |
| 2010 | 1 |
| 2011 | 6 |
| 2012 | 2 |
| 2013 | 4 |
| 2014 | 4 |
| 2015 | 4 |
| 2016 | 2 |
| 2017 | 4 |
| 2018 | 4 |
| 2019 | 4 |
| 2020 | 7 |
| 2021 | 5 |
| 2022 | 9 |
| 2023 | 4 |
| 2024 | 5 |
| 2025 | 6 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K251745 | Welch Allyn FlexiPort Blood Pressure Cuffs (FlexiPort Blood Pressure Cuffs) | DXQ | Substantially Equivalent | |
| K250508 | AK 98 Dialysis Machine (955607) | KDI | Substantially Equivalent | |
| K251640 | SIGMA Spectrum Infusion Pump with Master Drug Library | FRN | Substantially Equivalent | |
| K251636 | Spectrum IQ Infusion System with Dose IQ Safety Software (3570009) | FRN | Substantially Equivalent | |
| K243529 | Solution Administration Sets | FPA | Substantially Equivalent | |
| K242339 | Intravascular Extension Sets and Accessories | FPA | Substantially Equivalent | |
| K242390 | Novum IQ Syringe Pump (40800BAXUS) | FRN | Substantially Equivalent | |
| K241564 | Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE MIS | MQV | Substantially Equivalent | |
| K230665 | Dose IQ Safety Software | PHC | Substantially Equivalent | |
| K211122 | Novum IQ Large Volume Pump | FRN | Substantially Equivalent | |
| K231849 | MiniCap Extended Life PD Transfer Set with Twist Clamp - Code 5C4482A; MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Short - Code 5C4483 | KDJ | Substantially Equivalent | |
| K232467 | CleanCart A, CleanCart C, AK 98 Hemodialysis Machine | KDI | Substantially Equivalent | |
| K230041 | Spectrum IQ Infusion System with Dose IQ Safety Software | FRN | Substantially Equivalent | |
| K230022 | Baxter SIGMA Spectrum Infusion Pump with Master Drug Library | FRN | Substantially Equivalent | |
| K223175 | lntravascular Administration Sets with Stopcock and Manifold | FMG | Substantially Equivalent | |
| K220558 | Blood Administration Sets | BRZ | Substantially Equivalent | |
| K212262 | PCA Syringe Sets | FPA | Substantially Equivalent | |
| K222048 | Spectrum IQ Infusion System with Dose IQ Safety Software | FRN | Substantially Equivalent | |
| K211125 | Novum IQ Syringe Pump | FRN | Substantially Equivalent | |
| K211124 | Dose IQ Safety Software | PHC | Substantially Equivalent | |
| K220417 | Spectrum IQ Infusion System with Dose IQ Safety Software | FRN | Substantially Equivalent | |
| K212216 | Prismaflex ST60 Set, Prismaflex ST100 Set, Prismaflex ST150 set | KDI | Substantially Equivalent | |
| K214016 | 15L Cycler Drainage Bag | KDJ | Substantially Equivalent | |
| K213639 | Revaclear 500, Revaclear 400, Revaclear 300 | KDI | Substantially Equivalent | |
| K211649 | PCEA Syringe Set | PWH | Substantially Equivalent | |
| K211035 | U9000 Plus Ultrafilter | FIP | Substantially Equivalent | |
| K203609 | Intravascular Administration Sets | FPA | Substantially Equivalent | |
| K210430 | Intravascular Extension Set | FPA | Substantially Equivalent | |
| K210335 | Blood Administration Set | BRZ | Substantially Equivalent | |
| K201867 | Homechoice Claria APD System, Sharesource Connectivity Platform for Use with the Homechoice Claria APD System | FKX | Substantially Equivalent | |
| DEN190042 | Theranova Dialyzers, Theranova 400 Dialyzer, Theranova 500 Dialyzer | QAX | Unknown | |
| K192366 | Intravascular Extension Sets and Accessories | FPA | Substantially Equivalent | |
| K201464 | Altapore MIS | MQV | Substantially Equivalent | |
| K200640 | ALTAPORE SHAPE | MQV | Substantially Equivalent | |
| K193482 | PrisMax System Version 3 | KDI | Substantially Equivalent | |
| K192363 | Altapore | MQV | Substantially Equivalent | |
| K192705 | MiniCap Extended Life PD Transfer Sets | KDJ | Substantially Equivalent | |
| K191513 | Altapore Shape | MQV | Substantially Equivalent | |
| K190910 | PrisMax System Version 2 | KDI | Substantially Equivalent | |
| K180739 | Clearlink System Solution Set | FPA | Substantially Equivalent | |
| K181225 | ALTAPORE | MQV | Substantially Equivalent | |
| K181306 | Actifuse Flow | MQV | Substantially Equivalent | |
| K173084 | Spectrum IQ Infusion System, Dose IQ Safety Software | FRN | Substantially Equivalent | |
| K171671 | Prismaflex System 8.10 | KDI | Substantially Equivalent | |
| K172544 | IV Fat Emulsion Administration Sets | FPA | Substantially Equivalent | |
| K161808 | Solution Set with 1.2 Micron Air Eliminating Filter | FPA | Substantially Equivalent | |
| K163530 | PrisMax Control Unit | KDI | Substantially Equivalent | |
| K162887 | PrismaSATE | KPO | Substantially Equivalent | |
| K160007 | Paclitaxel Sets | FPA | Substantially Equivalent | |
| K161323 | Solution Set for Epidural Use | FPA | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1019003 | 1019003 | BAXTER HEALTHCARE CORPORATION | 911 NORTH DAVIS, CLEVELAND, MS 38732 US | 2026 | |
| 1025114 | 1025114 | BAXTER HEALTHCARE CORPORATION | 65 Pitts Station Road, MARION, NC 28752 US | 2026 | |
| 1416980 | 1416980 | BAXTER HEALTHCARE CORPORATION | 25212 W. ILLINOIS ROUTE 120, ROUND LAKE, IL 60073 US | 2026 | and 48 more, listed in full below |
| 1417572 | 1417572 | BAXTER HEALTHCARE CORPORATION | ONE BAXTER PARKWAY, DEERFIELD, IL 60015 US | 2026 | No device listings on this registration |
| 2025695 | 2025695 | BAXTER HEALTHCARE CORPORATION | 17511 Armstrong Ave, IRVINE, CA 92614 US | 2026 | |
| 2937398 | 2937398 | BAXTER HEALTHCARE CORPORATION | 21026 Alexander Court, HAYWARD, CA 94545 US | 2026 | |
| 1314492 | 1314492 | Baxter Healthcare Corporation | 711 PARK AVE., MEDINA, NY 14103 US | 2026 | |
| 3007319130 | 3007319130 | Baxter Healthcare Corporation | 600 SE Maritime Ave, Vancouver, WA 98661 US | 2026 | No device listings on this registration |
| 9612052 | 3002806443 | Baxter Healthcare, S.A. | Parque Industrial ITABO, Haina San Cristobal 21426 DO | 2026 | and 4 more, listed in full below |
| 2314912 | 2314912 | Vantive US Healthcare LLC | 1900 NORTH HIGHWAY 201, MOUNTAIN HOME, AR 72653 US | 2026 | |
| 3030306055 | 3030306055 | Vantive US Healthcare LLC | One Baxter Parkway, Deerfield, IL 60015 US | 2026 | |
| 3038195011 | 3038195011 | Vantive US Healthcare LLC | 510 Lake Cook Rd, Deerfield, IL 60015 US | 2026 | and 5 more, listed in full below |
| 3042639609 | 3042639609 | Vantive US Healthcare LLC | 8640 Nail Rd Ste 110, Olive Branch, MS 38654 US | 2026 | No device listings on this registration |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- EYIAdaptor, Ureteral Catheter
- CGXAlkaline Picrate, Colorimetry, Creatinine
- CJAAmyloclastic, Amylase
- CCEAnalyzer, Gas, Oxygen, Partial Pressure, Blood-Phase, Indwelling
- CACApparatus, Autotransfusion
- DXQBlood Pressure Cuff
- EKJBurnisher, Operative
- DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
- BSOCatheter, Conduction, Anesthetic
- DXECatheter, Embolectomy
- DYGCatheter, Flow Directed
- DQOCatheter, Intravascular, Diagnostic
- DQECatheter, Oximeter, Fiber-Optic
- DQYCatheter, Percutaneous
- EZLCatheter, Retention Type, Balloon
- CAICircuit, Breathing (W Connector, Adaptor, Y Piece)
- DXCClamp, Vascular
- DBAComplement C1 Inhibitor (Inactivator), Antigen, Antiserum, Control
- DXGComputer, Diagnostic, Pre-Programmed, Single-Function
- BZAConnector, Airway (Extension)
- CICCresolphthalein Complexone, Calcium
- DWPDilator, Vessel, Surgical
- DIFDrug Mixture Control Materials
- CEMElectrode, Ion Specific, Potassium
- FBWFiliform And Filiform Follower
- DPWFlowmeter, Blood, Cardiovascular
- BZEHeater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
- CFRHexokinase, Glucose
- DTJHolder, Heart-Valve, Prosthesis
- DYBIntroducer, Catheter
- CAKMicrofilter, Blood Transfusion
- CKANadh Oxidation/Nad Reduction, Alt/Sgpt
- CITNadh Oxidation/Nad Reduction, Ast/Sgot
- CAFNebulizer (Direct Patient Interface)
- BSPNeedle, Conduction, Anesthetic (W/Wo Introducer)
- ERAOtoscope
- DQAOximeter
- DTZOxygenator, Cardiopulmonary Bypass
- DXZPatch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
- CEOPhosphomolybdate (Colorimetric), Inorganic Phosphorus
- DSYProsthesis, Vascular Graft, Of 6mm And Greater Diameter
- DYFProsthesis, Vascular Graft, Of Less Then 6mm Diameter
- CHPRadioimmunoassay, Estradiol
- CFTRadioimmunoassay, Prolactin (Lactogen)
- CDXRadioimmunoassay, Total Thyroxine
- CDPRadioimmunoassay, Total Triiodothyronine
- CANRegulator, Pressure, Gas Cylinder
- DTNReservoir, Blood, Cardiopulmonary Bypass
- BRZSet, Blood Transfusion
- BZOSet, Tubing And Support, Ventilator (W Harness)
- DTISizer, Heart-Valve, Prosthesis
- DWXStripper, Artery, Intraluminal
- DHASystem, Test, Human Chorionic Gonadotropin
- DWJSystem, Thermal Regulating
- DRSTransducer, Blood-Pressure, Extravascular
- DXOTransducer, Pressure, Catheter Tip
- CDQUrease And Glutamic Dehydrogenase, Urea Nitrogen
- BSBWarmer, Blood, Non-Electromagnetic Radiation
- DQXWire, Guide, Catheter
- DQIWithdrawal/Infusion Pump
Recall records
Showing 25 of 768| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-3066-2026 | Baxter Novum IQ Syringe Pump, Loaner, Model Number 40800BAXUSL | A software issue that may occur during a Volume/Time (VOT) multi-syringe infusion when a syringe reaches empty and is replaced while a Volume To Be Infused (VTBI) remains. | Class II | Open, Classified | |
| Z-3065-2026 | Baxter Novum IQ Syringe Pump, Model Number 40800BAXUS | A software issue that may occur during a Volume/Time (VOT) multi-syringe infusion when a syringe reaches empty and is replaced while a Volume To Be Infused (VTBI) remains. | Class II | Open, Classified | |
| Z-2766-2026 | Baxter Duo-Vent Solution Set and Male Luer Lock Adapter, Product Code 1C8507; Solution Administration Sets | Baxter received customer reports of air bubbles in the drip chamber and tubing when a pressure cuff is in use or when the tubing is flushed at the fully open position. | Class I | Open, Classified | |
| Z-2551-2026 | Hillrom VOLARA System P.CIRCUIT 5KIT AC, (Single Patient Use Circuit), Model/Catalog Number REF M08474; Oscillation Lung Expansion Therapy, positive pressure breathing device | There have been reports of air and medication leakage from the nebulizer cup during therapy of Volara system patient circuits. The leakage can lead to an oxygen level drop in the patient and ineffective nebulization, which may affect the delivery of the prescribed treatment. The issue has been associated with improper locking of the nebulizer cup after adding medication during user setup. | Class I | Open, Classified | |
| Z-2550-2026 | Hillrom VOLARA System P.CIRCUIT KIT AC (Single Patient Use Circuit), Model/Catalog Number REF M08473; Oscillation Lung Expansion Therapy, positive pressure breathing device | There have been reports of air and medication leakage from the nebulizer cup during therapy of Volara system patient circuits. The leakage can lead to an oxygen level drop in the patient and ineffective nebulization, which may affect the delivery of the prescribed treatment. The issue has been associated with improper locking of the nebulizer cup after adding medication during user setup. | Class I | Open, Classified | |
| Z-2549-2026 | Hillrom VOLARA P.CIRCUIT 5KIT (System Single Patient Use Circuit), Model/Catalog Number REF M08270; Oscillation Lung Expansion Therapy, positive pressure breathing device | There have been reports of air and medication leakage from the nebulizer cup during therapy of Volara system patient circuits. The leakage can lead to an oxygen level drop in the patient and ineffective nebulization, which may affect the delivery of the prescribed treatment. The issue has been associated with improper locking of the nebulizer cup after adding medication during user setup. | Class I | Open, Classified | |
| Z-2548-2026 | Hillrom VOLARA System P.CIRCUIT KIT (Single Patient Use Circuit), Model/Catalog Number REF M08085; Oscillation Lung Expansion Therapy, positive pressure breathing device | There have been reports of air and medication leakage from the nebulizer cup during therapy of Volara system patient circuits. The leakage can lead to an oxygen level drop in the patient and ineffective nebulization, which may affect the delivery of the prescribed treatment. The issue has been associated with improper locking of the nebulizer cup after adding medication during user setup. | Class I | Open, Classified | |
| Z-2262-2026 | Brand Name: Exacta Mix Product Name: Vented Micro-Volume Inlet Model/Catalog Number: H938175 Product Description: Tubing sets with push-on connector on one end (to attach to the Fluid Selector Valve) and a spike or other appropriate connector on the opposite end to attach the source container. | Affected lots may contain incorrect 0.8-micron filters. Use of a 0.8-micron filter in place of the validated 3-micron filter may lead to reduced flow efficiency, incomplete or slower transfers of ingredients, or system alarms. This issue may lead to clinical effects such as electrolyte imbalance, metabolic instability, delayed recovery, etc. | Class II | Open, Classified | |
| Z-2638-2026 | Adapter for Head Positioning, Model/Catalog Number: 1739994, when used in conjunction with the side rails of the Upper Back Section H V U component (product code 1909813) on Baxter operating tables | The Adapter for Head Positioning accessory may become loose during patient positioning and unintentionally move when used in conjunction with the side rails of the Upper Back Section H V U component on Baxter operating tables. | Class II | Open, Classified | |
| Z-1637-2026 | Blue Ventilator Adapter Module, single-patient use circuit, Product Code M07937. Accessory to Baxter Volara Respiratory Therapy system. | Urgent Medical Device Correction for the Volara system single-patient use circuit due to the potential that patients or caregivers may be unaware of a possible decrease in oxygen levels (oxygen desaturation), or potential lung tissue injury from overexpansion (barotrauma) when the Volara device is used in the home care environment. This correction is providing the home caregiver specific instructions for use. | Class I | Open, Classified | |
| Z-1573-2026 | Brand Name: Welch Allyn, Inc. Product Name: Welch Allyn Spot Vision Screener VS100 Model/Catalog Number: VS100 Software Version: Software version 3.2.0.1 Product Description: Welch Allyn Spot Vision Screener VS100, FDA product code name: Refractometer, ophthalmic One unit per package | Display screen may unintentionally flicker due to a software issue. Exposure to flickering lights may induce photosensitive seizure activity in susceptible individuals. | Class II | Open, Classified | |
| Z-1368-2026 | Brand Name: Spectrum IQ Product Name: Infusion Pump Model/Catalog Number: 3570009 Software Version: N/A Product Description: Infusion Pump, one unit per carton Component: N/A | Pumps were released without full testing being performed, including occlusion alarm testing. | Class II | Open, Classified | |
| Z-1231-2026 | PRISMAFLEX TPE2000 SET, Product Code 114093; Dialyzer, High Permeability With Or Without Sealed Dialysate System | There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit. | Class II | Open, Classified | |
| Z-1230-2026 | PRISMAFLEX HF1000 SET, Product Code 107142; Dialyzer, High Permeability With Or Without Sealed Dialysate System | There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit. | Class II | Open, Classified | |
| Z-1229-2026 | PRISMAFLEX HF1000 SET, Product Code 107140; Dialyzer, High Permeability With Or Without Sealed Dialysate System | There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit. | Class II | Open, Classified | |
| Z-1228-2026 | PRISMAFLEX M150 SET, Product Code 109990; Dialyzer, High Permeability With Or Without Sealed Dialysate System | There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit. | Class II | Open, Classified | |
| Z-1227-2026 | PRIMSAFLEX M100 SET, Product Code 106697; Dialyzer, High Permeability With Or Without Sealed Dialysate System | There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit. | Class II | Open, Classified | |
| Z-1226-2026 | OXIRIS SET, Product Code 112016; Dialyzer, High Permeability With Or Without Sealed Dialysate System | There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit. | Class II | Open, Classified | |
| Z-1225-2026 | PRISMAFLEX ST150 SET US, Product Code 107640US; Dialyzer, High Permeability With Or Without Sealed Dialysate System | There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit. | Class II | Open, Classified | |
| Z-1224-2026 | PRISMAFLEX ST100 SET US, Product Code 107636US; Dialyzer, High Permeability With Or Without Sealed Dialysate System | There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit. | Class II | Open, Classified | |
| Z-1121-2026 | SIGMA Spectrum Infusion Pump, Model/Catalog Number: 35700BAX2 | Certain pumps have potentially been released from service with defective grease applied to the cam and motor gears. Due to its low viscosity, the defective grease may lead to the device having insufficient lubrication on the cam, which could lead to premature wear of the mechanism assembly, resulting in over-infusion or a free-flow situation. | Class II | Open, Classified | |
| Z-0847-2026 | Welch Allyn INF BAG, Thigh 1-Tube, Model/Catalog Number: REF 5089-18; Product replacement bladder for the Welch Allyn Two-Piece Blood Pressure Cuff. | Replacement bladder kit for the Welch Allyn two-piece reusable blood pressure cuff may contain a Large Adult size bladder rather than a Thigh size bladder in the replacement kits. | Class II | Open, Classified | |
| Z-0233-2026 | Oral Probe (Product code 02893-000), accessory used with Welch Allyn SureTemp Plus 690 (Product codes 01690-200 and 01690-400) Thermometers and Welch Allyn SureTemp Plus 692 (01692-200) thermometers | Affected oral/axillary probes were inadvertently programmed with the rectal probe configuration. Affected probes will potentially display a lower temperature than the true value, which may lead to a delay in managing fever-related symptoms or infection. | Class II | Open, Classified | |
| Z-0204-2026 | CLEARLINK SYSTEM NON-DEHP CONTINU-FLO SOLN SET, 96" (2,4 m), Product Code: 2H8519 | IV sets may leak. | Class II | Open, Classified | |
| Z-0203-2026 | CLEARLINK System Paclitaxel Set, Non-Vented with Polyethylene Lined Tubing and CLEARLINK Luer Activated Valve, 0.2 Micron Filter, CLEARLINK Luer Activated Valve, 10 drops/mL, 107-inch (2.7 meters), Product Code 2R8858 | IV sets may leak. | Class II | Open, Classified |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain