Company ยท US
Baxter Healthcare Corp
FDA 510(k) clearances and medical device recalls filed under this name, 1977 to 2025. Name variants (Inc, Corp, punctuation) are merged.
569510(k) clearances (1 in 12 months)
753recalls (19 in 12 months)
569recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| FPA | Set, Administration, Intravascular | 218 |
| FRN | Pump, Infusion | 179 |
| KDI | Dialyzer, High Permeability With Or Without Sealed Dialysate System | 78 |
| KDJ | Set, Administration, For Peritoneal Dialysis, Disposable | 65 |
| LHI | Set, I.V. Fluid Transfer | 38 |
| FMG | Stopcock, I.V. Set | 36 |
| FKX | System, Peritoneal, Automatic Delivery | 30 |
| KPE | Container, I.V. | 18 |
| MEB | Pump, Infusion, Elastomeric | 18 |
| IOQ | Bed, Flotation Therapy, Powered | 17 |
| JEA | Table, Surgical With Orthopedic Accessories, Ac-Powered | 14 |
| GDC | Table, Operating-Room, Electrical | 13 |
| CBK | Ventilator, Continuous, Facility Use | 12 |
| FJK | Set, Tubing, Blood, With And Without Anti-Regurgitation Valve | 12 |
| BRZ | Set, Blood Transfusion | 11 |
| KSB | Set, Transfer (Blood/Plasma) | 11 |
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 10 |
| KYX | Dispenser, Liquid Medication | 10 |
| MEA | Pump, Infusion, Pca | 10 |
| MQV | Filler, Bone Void, Calcium Compound | 10 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 16, 2025 | K251745 | Welch Allyn FlexiPort Blood Pressure Cuffs (FlexiPort Blood Pressure Cuffs) Baxter Healthcare Corporation | DXQ |
| Jul 28, 2025 | K251640 | SIGMA Spectrum Infusion Pump with Master Drug Library Baxter Healthcare Corporation | FRN |
| Jul 28, 2025 | K251636 | Spectrum IQ Infusion System with Dose IQ Safety Software (3570009) Baxter Healthcare Corporation | FRN |
| Mar 14, 2025 | K243529 | Solution Administration Sets Baxter Healthcare Corporation | FPA |
| Feb 28, 2025 | K242339 | Intravascular Extension Sets and Accessories Baxter Healthcare Corporation | FPA |
| Sep 5, 2024 | K242390 | Novum IQ Syringe Pump (40800BAXUS) Baxter Healthcare Corporation | FRN |
| Aug 2, 2024 | K241564 | Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE MIS Baxter Healthcare Corporation | MQV |
| Mar 29, 2024 | K230665 | Dose IQ Safety Software Baxter Healthcare Corporation | PHC |
| Mar 29, 2024 | K211122 | Novum IQ Large Volume Pump Baxter Healthcare Corporation | FRN |
| Mar 12, 2024 | K231849 | MiniCap Extended Life PD Transfer Set with Twist Clamp - Code 5C4482A; MiniCap Extended Life PD Transfer Set with Twist Baxter Healthcare | KDJ |
| Sep 14, 2023 | K232467 | CleanCart A, CleanCart C, AK 98 Hemodialysis Machine Baxter Healthcare Corporation | KDI |
| Mar 31, 2023 | K230041 | Spectrum IQ Infusion System with Dose IQ Safety Software Baxter Healthcare Corporation | FRN |
| Mar 31, 2023 | K230022 | Baxter SIGMA Spectrum Infusion Pump with Master Drug Library Baxter Healthcare Corporation | FRN |
| Mar 10, 2023 | K223175 | lntravascular Administration Sets with Stopcock and Manifold Baxter Healthcare Corporation | FMG |
| Nov 17, 2022 | K220558 | Blood Administration Sets Baxter Healthcare Corporation | BRZ |
| Oct 3, 2022 | K212262 | PCA Syringe Sets Baxter Healthcare Corporation | FPA |
| Sep 6, 2022 | K222048 | Spectrum IQ Infusion System with Dose IQ Safety Software Baxter Healthcare Corporation | FRN |
| Aug 30, 2022 | K211125 | Novum IQ Syringe Pump Baxter Healthcare Corporation | FRN |
| Aug 30, 2022 | K211124 | Dose IQ Safety Software Baxter Healthcare Corporation | PHC |
| Apr 29, 2022 | K220417 | Spectrum IQ Infusion System with Dose IQ Safety Software Baxter Healthcare Corporation | FRN |
| Apr 1, 2022 | K212216 | Prismaflex ST60 Set, Prismaflex ST100 Set, Prismaflex ST150 set Baxter Healthcare Corporation | KDI |
| Mar 18, 2022 | K214016 | 15L Cycler Drainage Bag Baxter Healthcare Corporation | KDJ |
| Jan 24, 2022 | K213639 | Revaclear 500, Revaclear 400, Revaclear 300 Baxter Healthcare Corporation | KDI |
| Nov 23, 2021 | K211649 | PCEA Syringe Set Baxter Healthcare Corporation | PWH |
| Oct 19, 2021 | K211035 | U9000 Plus Ultrafilter Baxter Healthcare Corporation | FIP |
| Sep 30, 2021 | K203609 | Intravascular Administration Sets Baxter Healthcare Corporation | FPA |
| Jun 18, 2021 | K210430 | Intravascular Extension Set Baxter Healthcare Corporation | FPA |
| Jun 10, 2021 | K210335 | Blood Administration Set Baxter Healthcare Corporation | BRZ |
| Nov 19, 2020 | K201867 | Homechoice Claria APD System, Sharesource Connectivity Platform for Use with the Homechoice Claria APD System Baxter Healthcare Corporation | FKX |
| Aug 28, 2020 | DEN190042 | Theranova Dialyzers, Theranova 400 Dialyzer, Theranova 500 Dialyzer Baxter Healthcare Corporation | QAX |
| Jul 20, 2020 | K192366 | Intravascular Extension Sets and Accessories Baxter Healthcare Corporation | FPA |
| Jun 30, 2020 | K201464 | Altapore MIS Baxter Healthcare Corporation | MQV |
| May 8, 2020 | K200640 | ALTAPORE SHAPE Baxter Healthcare Corporation | MQV |
| Mar 13, 2020 | K193482 | PrisMax System Version 3 Baxter Healthcare Corporation | KDI |
| Jan 9, 2020 | K192363 | Altapore Baxter Healthcare Corporation | MQV |
| Oct 25, 2019 | K192705 | MiniCap Extended Life PD Transfer Sets Baxter Healthcare | KDJ |
| Oct 19, 2019 | K191513 | Altapore Shape Baxter Healthcare Corporation | MQV |
| Jul 25, 2019 | K190910 | PrisMax System Version 2 Baxter Healthcare Corp | KDI |
| May 28, 2019 | K180739 | Clearlink System Solution Set Baxter Healthcare Corporation | FPA |
| Aug 31, 2018 | K181225 | ALTAPORE Baxter Healthcare Corporation | MQV |
| Aug 17, 2018 | K181306 | Actifuse Flow Baxter Healthcare Corporation | MQV |
| May 11, 2018 | K173084 | Spectrum IQ Infusion System, Dose IQ Safety Software Baxter Healthcare Corporation | FRN |
| Feb 23, 2018 | K171671 | Prismaflex System 8.10 Baxter Healthcare Corporation | KDI |
| Sep 22, 2017 | K172544 | IV Fat Emulsion Administration Sets Baxter Healthcare Corporation | FPA |
| Jun 21, 2017 | K161808 | Solution Set with 1.2 Micron Air Eliminating Filter Baxter Healthcare Corporation | FPA |
| May 3, 2017 | K163530 | PrisMax Control Unit Baxter Healthcare Corp | KDI |
| Jan 6, 2017 | K162887 | PrismaSATE Baxter Healthcare Corporation | KPO |
| Dec 19, 2016 | K160007 | Paclitaxel Sets Baxter Healthcare Corporation | FPA |
| Nov 30, 2016 | K161323 | Solution Set for Epidural Use Baxter Healthcare Corporation | FPA |
| Dec 28, 2015 | K153158 | Solution Administration Sets with 0.2 Micron Filter Baxter Healthcare Corporation | FPA |
Newest 50 of 569.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 13, 2026 | Baxter Healthcare Corporation Likorall Overhead Lifts
Product Code: 3121001
Product Description: LIKORALL 200
Product Code: 3122005
Product Description: LIKORALL 242 ES, NATURAL
Product Code: 3122005NA
Product Description: LIKO Open, Classified |
FSA | None listed |
| Sep 24, 2026 | Baxter Healthcare Corporation PRO+ 40" MRS SURFACE, mattress with Advanced Microclimate Technology (AMT) uses a non-powered system of intake and output valves to provide weight-based pressure redistribution whenever a patient move Open, Classified |
IOQ | None listed |
| Sep 24, 2026 | Baxter Healthcare Corporation PRO+ 36" MRS SURFACE, mattress with Advanced Microclimate Technology (AMT) uses a non-powered system of intake and output valves to provide weight-based pressure redistribution whenever a patient move Open, Classified |
IOQ | None listed |
| Sep 24, 2026 | Baxter Healthcare Corporation PRO+ MRS SURFACE FOR VERSACARE, mattress with Advanced Microclimate Technology (AMT) uses a non-powered system of intake and output valves to provide weight-based pressure redistribution whenever a pa Open, Classified |
IOQ | None listed |
| Sep 23, 2026 | Baxter Healthcare Corporation Brand Name: VOLARA System
Product Name: VOLARA, HC, NA A
Model/Catalog Number: M08594A
Software Version: N/A
Product Description: VOLARA, HOMECARE, NORTH AMERICA
Component: No Open, Classified |
NHJ | K200988 |
| Aug 31, 2026 | Baxter Healthcare Corporation Baxter Novum IQ Syringe Pump, Loaner, Model Number 40800BAXUSL Open, Classified |
FRN | K242390 |
| Aug 31, 2026 | Baxter Healthcare Corporation Baxter Novum IQ Syringe Pump, Model Number 40800BAXUS Open, Classified |
FRN | K242390 |
| Aug 11, 2026 | Baxter Healthcare Corporation Baxter Duo-Vent Solution Set and Male Luer Lock Adapter, Product Code 1C8507; Solution Administration Sets Open, Classified |
FPA | K243529 |
| Jul 1, 2026 | Baxter Healthcare Corporation Hillrom VOLARA System P.CIRCUIT 5KIT AC, (Single Patient Use Circuit), Model/Catalog Number REF M08474; Oscillation Lung Expansion Therapy, positive pressure breathing device Open, Classified |
NHJ | K192143 K200988 |
| Jul 1, 2026 | Baxter Healthcare Corporation Hillrom VOLARA System P.CIRCUIT KIT AC (Single Patient Use Circuit), Model/Catalog Number REF M08473; Oscillation Lung Expansion Therapy, positive pressure breathing device Open, Classified |
NHJ | K192143 K200988 |
| Jul 1, 2026 | Baxter Healthcare Corporation Hillrom VOLARA P.CIRCUIT 5KIT (System Single Patient Use Circuit), Model/Catalog Number REF M08270; Oscillation Lung Expansion Therapy, positive pressure breathing device Open, Classified |
NHJ | K192143 K200988 |
| Jul 1, 2026 | Baxter Healthcare Corporation Hillrom VOLARA System P.CIRCUIT KIT (Single Patient Use Circuit), Model/Catalog Number REF M08085; Oscillation Lung Expansion Therapy, positive pressure breathing device Open, Classified |
NHJ | K192143 K200988 |
| Jul 1, 2026 | Baxter Healthcare Corporation 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 Open, Classified |
GDC | None listed |
| May 29, 2026 | Baxter Healthcare Corporation 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 Open, Classified |
NEP | K002705 |
| Apr 1, 2026 | Baxter Healthcare Corporation Blue Ventilator Adapter Module, single-patient use circuit, Product Code M07937. Accessory to Baxter Volara Respiratory Therapy system. Open, Classified |
NHJ | K192143 K200988 |
| Mar 18, 2026 | Baxter Healthcare Corporation 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 S Open, Classified |
HKO | None listed |
| Feb 13, 2026 | Baxter Healthcare Corporation 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 Open, Classified |
FRN | K251636 |
| Jan 16, 2026 | Baxter Healthcare Corporation SIGMA Spectrum Infusion Pump, Model/Catalog Number: 35700BAX2 Open, Classified |
FRN | K251640 |
| Dec 1, 2025 | Baxter Healthcare Corporation 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. Open, Classified |
DXQ | None listed |
| Oct 23, 2025 | Baxter Healthcare Corporation 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 Open, Classified |
FLL | K030580 |
| Oct 16, 2025 | Baxter Healthcare Corporation CLEARLINK SYSTEM NON-DEHP CONTINU-FLO SOLN SET, 96" (2,4 m), Product Code: 2H8519 Open, Classified |
FMG | None listed |
| Oct 16, 2025 | Baxter Healthcare Corporation 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), Pr Open, Classified |
FMG | K180739 |
| Oct 16, 2025 | Baxter Healthcare Corporation CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK Luer Activated Valves, Backcheck Valve, 10 drops/mL, 120-inch (3.0 meters), Non-DEHP, Product Code 2R8537 Open, Classified |
FMG | K180739 |
| Oct 16, 2025 | Baxter Healthcare Corporation CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves. 10 drops/mL, 96-inch (2.4 meters). Non-DEHP, Product Code 2R8519 Open, Classified |
FMG | K180739 |
| Oct 16, 2025 | Baxter Healthcare Corporation CLEARLINK System Non_DEHP Extenstion Set, Straight-Type Extension Set, Standard Bore,
1.2 Micron Filter, CLEARLINK Luer Activated Valve, 19-inch (47 centimeters), Product Code 2H8603 Open, Classified |
FMG | K952074 |
| Oct 16, 2025 | Baxter Healthcare Corporation CLEARLINK SYSTEM EXTENSION SET, Straight-Type Extension Set, Standard Bore,
CLEARLINK Luer Activated Valve, Retractable Collar, 7.9-inch (20 centimeters), Product Code 2C8634 Open, Classified |
FMG | K112893 |
| Oct 16, 2025 | Baxter Healthcare Corporation CLEARLINK SYSTEM EXTENSION SET, Straight-Type Extension Set, Standard Bore, CLEARLINK Luer Activated Valve, Retractable Collar, 14-inch (35 centimeters), Product Code 2C8632 Open, Classified |
FMG | K112893 |
| Oct 16, 2025 | Baxter Healthcare Corporation CLEARLINK SYSTEM EXTENSION SET, Straight-Type Extension Set, Standard Bore,
CLEARLINK Luer Activated Valve, Retractable Collar, 44-inch (111 centimeters), Product code 2C8610 Open, Classified |
FMG | K112893 |
| Oct 16, 2025 | Baxter Healthcare Corporation CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, 0.2 Micron Filter, three CLEARLINK Luer Activated Valves, Backcheck Valve, 10 drops/mL, 102-inch (2.6 meters), Product Code 2C8593 Open, Classified |
FMG | K153158 |
| Oct 16, 2025 | Baxter Healthcare Corporation CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, 0.2 Micron Filter, two CLEARLINK Luer Activated Valves, Backcheck Valve, 10 drops/mL, 104-inch (2.6 meters), Product Code 2C8571 Open, Classified |
FMG | K153158 |
| Oct 16, 2025 | Baxter Healthcare Corporation CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK Luer Activated Valves, Backcheck Valve, Retractable Collar, 10 drops/mL, 120-inch (3.0 meters), Product Code 2C8541 Open, Classified |
FMG | K203609 |
| Oct 16, 2025 | Baxter Healthcare Corporation CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK Luer Activated Valves, Backcheck Valve, Retractable Collar, 10 drops/mL, 120-inch (3.0 meters), Product Code 2C8537 Open, Classified |
FMG | K203609 |
| Oct 16, 2025 | Baxter Healthcare Corporation CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves, Backcheck Valve, 10 drops/mL, 112-inch (2.8 meters), Product Code 2C8519 Open, Classified |
FMG | K203609 |
| Oct 16, 2025 | Baxter Healthcare Corporation CLEARLINK SYSTEM Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves, 10 drops/mL, 100-inch (2.5 meters), Product Code 2C8425 Open, Classified |
FMG | K112893 |
| Oct 16, 2025 | Baxter Healthcare Corporation CLEARLINK System Solution Set, DUO-VENT, CLEARLINK Luer Activated Valve, 10 drops/mL, 92-inch (2.3 meters), Product code 2C8419 Open, Classified |
FMG | K112893 |
| Oct 16, 2025 | Baxter Healthcare Corporation CONTINU-FLO Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves, Backcheck Valve, Plus 4-Way Stopcock Extension Set with two CLEARLINK Luer Activated Valve, Pfoduct code 2C6255 Open, Classified |
FMG | K130245 |
| Sep 19, 2025 | Baxter Healthcare Corporation Baster Continu-Flo Solution Set, Non-Vented, 2 Clearlink Luer Activated Valves, Backcheck Valve. 10 drops/mL. 112" (2.8 m), Product Code REF 2C8519; intravascular administration set Open, Classified |
FPA | K203609 |
| Aug 29, 2025 | Baxter Healthcare Corporation Novum IQ Syringe Pump, Product Code 40700BAX, infusion pump Open, Classified |
FRN | None listed |
| Aug 29, 2025 | Baxter Healthcare Corporation Novum IQ Syringe Pump, Product Code 40800BAXUS, infusion pump Open, Classified |
FRN | K242390 |
| Aug 29, 2025 | Baxter Healthcare Corporation Novum IQ LVP (Large Volume Pump), Product Code 40700BAXUS, infusion pump Open, Classified |
FRN | K211122 |
| Aug 22, 2025 | Baxter Healthcare Corporation Spectrum IQ Infusion Pump, Product Code 3570009 Open, Classified |
FRN | K230041 |
| Aug 14, 2025 | Baxter Healthcare Corporation Baxter Novum IQ Large Volume Pump, Product Code REF 40700BAXUS Open, Classified |
FRN | K211122 |
| Jul 17, 2025 | Baxter Healthcare Corporation Baxter SIGMA Spectrum Infusion Pump V8, Model Number 35700BAX2 Open, Classified |
PHC | K230022 |
| Jul 17, 2025 | Baxter Healthcare Corporation Baxter SIGMA Spectrum Infusion Pump V6, Model Number 35700BAX Open, Classified |
PHC | K133801 |
| Jul 9, 2025 | Baxter Healthcare Corporation Hillrom LikoScale component, Product Code 3156232, used with the following adapter kits for patient lifts:
1) LikoScale 200 Accessory - Product Code 3156225;
2) LikoScale 350 Accessory - Product C Open, Classified |
FSA | None listed |
| Jul 9, 2025 | Baxter Healthcare Corporation Hillrom Q-Link 13 component, Product Code 3156509, used with the following Mobile Patient Lifts:
1) Uno 102 EE Mobile lift - Product Code 2010004;
2) Viking L Mobile lift - Product Code 2040044;
3 Open, Classified |
FSA | None listed |
| Jun 12, 2025 | Baxter Healthcare Corporation Baxter Novum IQ Syringe Pump, product code 40800BAXUS, Open, Classified |
FRN | K242390 |
| Jun 11, 2025 | Baxter Healthcare Corporation 2.5 V replacement rechargeable batteries for Hillrom WELCH ALLYN PocketScope handles, Product Code 72600 Open, Classified |
ERA | None listed |
| May 23, 2025 | Baxter Healthcare Corporation Affinity 4 Birthing Bed, Product Codes P3700E100429, P3700E100432, P3700E100433, P3700E100434, P3700E100435, P3700E100436, P3700E100437, P3700E100438, P3700E100439, P3700E100441, P3700E100442, P3700E1 Open, Classified |
KNC | None listed |
| May 20, 2025 | Baxter Healthcare Corporation Baxter Novum IQ LVP INFUSION SYSTEM, REF 40700BAXUS Open, Classified |
FRN | K211122 |
Newest 50 of 753.