Abbott LifeCare 1050 Controller
by Abbott Laboratories 510(k)
Active
510(k) K842080
Overview
The Abbott LifeCare 1050 Controller is an electronic infusion pump designed for intravascular administration of fluids in a hospital setting. Classified under product code LDR as a controller for infusion devices, it delivers precise, programmable dosing to patients requiring intravenous therapy.
This device is intended for use in general hospital environments and has received FDA 510(k) clearance under the Traditional review pathway. Supplied as a reusable medical device, it adheres to regulatory standards outlined in 21 CFR 880.5725 and is classified as a Class II device under special controls. No information regarding sterility or MRI safety is provided in the specifications.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK842080 | Date18 Jul 1984 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- LDR
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.5725
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Other devices from Abbott Laboratories
Questions
Is the Abbott LifeCare 1050 Controller intended for single-use or can it be reused in a hospital setting?
The Abbott LifeCare 1050 Controller is explicitly described as a reusable medical device. Since it is designed for hospital use and not labeled as single-use, it can be cleaned, maintained, and reused across multiple patients, provided it adheres to facility protocols for reprocessing and regulatory standards.
What types of intravenous therapies can the Abbott LifeCare 1050 Controller administer, and is it limited to specific fluid types?
The device is an electronic infusion pump intended for intravascular administration of fluids in a hospital setting. While it delivers precise, programmable dosing, the exact types of fluids it can administer are not specified in the provided data. Clinicians should refer to the manufacturer’s instructions for compatibility with specific medications or solutions, as this device is not limited to a single fluid type but is designed for general intravenous therapy.
How is the Abbott LifeCare 1050 Controller regulated, and what does its FDA clearance status mean for hospitals?
The device received FDA 510(k) clearance under the Traditional review pathway, meaning it was determined to be substantially equivalent to a legally marketed predicate device. This clearance confirms it meets U.S. safety and performance standards for Class II medical devices under 21 CFR 880.5725, allowing hospitals to use it for its intended purpose—programmable intravenous fluid delivery—while adhering to standard hospital protocols for infusion pumps.
Does the Abbott LifeCare 1050 Controller come with any specific storage or handling instructions, particularly regarding sterility?
The provided data does not mention sterility for the Abbott LifeCare 1050 Controller, as it is a reusable device. Since it is not sterile by design, hospitals must follow reprocessing guidelines (cleaning, disinfection, and sterilization) before reuse. Always consult the manufacturer’s instructions for proper storage and maintenance to ensure safe, repeated use in clinical settings.