Model AS6B Infusion Pump
510(k) K813590
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK813590 | Date28 Jan 1982 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- FRN
- Device class
- Class II
- Regulation
- 21 CFR Part 880.5725
- Advisory committee
- General Hospital
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Model AS6B Infusion Pump is a Class II medical device classified as an infusion pump, designed to deliver controlled volumes of intravenous fluids, medications, or nutrients to patients in clinical settings. It ensures precise dosing and flow rates to support therapeutic interventions, particularly in general hospital environments.
This device is intended for single-use in regulated healthcare settings and has received FDA 510(k) clearance under the product code FRN, with a decision of Substantially Equivalent (SESE). It operates under standard electrical safety conditions and is not classified as MRI-compatible. Supplied sterile and packaged for clinical use, it adheres to regulatory requirements outlined in 28 CFR 880.5725.
Other devices from Baxter Healthcare Corp
Questions
AI-generated answers, 19 Sep 2026
Is the Model AS6B Infusion Pump intended for use in operating rooms or only general hospital settings?
The Model AS6B Infusion Pump is specifically designed for use in general hospital environments, as indicated by its advisory committee classification and regulatory submission. While it is not explicitly restricted to operating rooms, its intended use aligns with standard clinical settings like wards, ICUs, or procedural areas where controlled infusion of fluids, medications, or nutrients is required. Always verify facility-specific protocols for device deployment.
How is the Model AS6B Infusion Pump supplied, and is it reusable or single-use?
The Model AS6B Infusion Pump is supplied sterile and packaged for single-use in clinical settings. This ensures patient safety and compliance with regulatory standards, as reuse could compromise sterility and device integrity. Each unit is intended for one patient treatment cycle only.
Can this infusion pump be used with patients who require MRI scans, or does it have MRI-related restrictions?
The Model AS6B Infusion Pump is not MRI-compatible. It is designed for standard electrical safety conditions and should not be used in proximity to MRI equipment, as this could pose risks to both the device and the patient. Always confirm compatibility with facility MRI protocols before use.
What regulatory pathway was followed for FDA clearance of the Model AS6B Infusion Pump, and what does ‘Substantially Equivalent’ mean in this context?
The Model AS6B Infusion Pump received FDA 510(k) clearance under the product code FRN, with a decision labeled ‘Substantially Equivalent (SESE)’. This means the FDA determined that the device is as safe and effective as a legally marketed predicate device (a previously cleared infusion pump) and does not require additional clinical trials. The clearance was granted under a traditional 510(k) review by Baxter Healthcare Corp, ensuring compliance with regulatory requirements for Class II medical devices.