Baxter Corp.
US Last updated 23 May 2026
- Devices
- 1
- Registries
- FDA 510(k)FDA
- FDA recalls
- 0
Catalogue
Auto Syringe AS40A Infusion Pump Ref K940147
FDA establishments
- Baxter SA LESSINES Hainaut · BE FEI 3005468265
- Baxter Limited Marsa · MT FEI 3003704957
What Baxter Corp. makes
Baxter Corp. manufactures the AUTO SYRINGE AS40A, a Class II infusion pump designed for controlled delivery of fluids and medications via syringe-based infusion systems.
The infusion pump is regulated under the FDA’s 510(k) pathway as a Class II device and is listed in the FDA’s 510(k) database. The company is based in the United States.
Frequently asked questions
What types of medical devices does Baxter Corp. manufacture?
Baxter Corp. manufactures infusion pumps, specifically the AUTO SYRINGE AS40A. This device is designed for the controlled delivery of fluids and medications through syringe-based infusion systems, ensuring precise dosing in clinical settings.
Where is Baxter Corp. based, and how does that affect its regulatory oversight?
Baxter Corp. is based in the United States. Since the company operates within the U.S., its devices are subject to FDA regulations. The AUTO SYRINGE AS40A, for example, is classified as a Class II device under FDA guidelines, meaning it undergoes specific regulatory controls to ensure safety and effectiveness.
Which regulatory registries or databases list Baxter Corp.’s devices?
Baxter Corp.’s devices, such as the AUTO SYRINGE AS40A, are listed in the FDA’s 510(k) database. This registry tracks devices that have been cleared through the FDA’s 510(k) premarket notification process, which is used for Class II devices like infusion pumps.
How are Baxter Corp.’s devices classified under medical device regulations?
Baxter Corp.’s devices, including the AUTO SYRINGE AS40A, are classified as Class II medical devices by the FDA. This classification is based on the level of risk associated with the device. Class II devices require special controls in addition to general controls to ensure their safety and performance, such as performance standards or post-market surveillance.
Information
- Country
- US