Baxter AS40A, AS41 Syringe Pump, Model N61WC
510(k) K012262
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK012262 | Date12 Sep 2001 | 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- Withdrawn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
- MRZ
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.5725
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Baxter AS40A and AS41 Syringe Pump, Model N61WC, is an infusion pump designed to deliver precise volumes of fluids or medications through a syringe. It operates as an accessory within infusion systems, enabling controlled administration for therapeutic purposes in clinical settings. The device is classified as a Class II medical device under FDA regulations, intended for use in general hospital environments. Its primary function is to automate the delivery of fluids at programmable rates, ensuring accurate dosing for patient care.
This syringe pump is supplied as a reusable medical device, intended for integration into existing infusion pump systems. It requires maintenance and repair by biomedical equipment technicians, with replacement components such as the battery pack (Model N61WC) restoring operational functionality. The device is not sterile and is not intended for direct patient contact; it must be cleaned and serviced according to manufacturer guidelines. Authorized for use in the United States under an FDA 510(k) clearance, it adheres to regulatory standards for infusion pump accessories, including compliance with regulation number 880.5725.