Abbott Acclaim Encore, Model 12237
by Abbott Laboratories 510(k)
Active
510(k) K011096
Overview
The Abbott Acclaim Encore, Model 12237 is a Pump, Infusion (product code FRN), classified under FDA regulation 880.5725 as a Class II device under Special Controls. This device is designed to deliver intravenous fluids, medications, or nutrients to patients in controlled, programmable doses, ensuring precise administration in clinical settings such as general hospitals.
The device is intended for single-use and is supplied sterile, adhering to regulatory standards for infusion pumps. It is not MRI-compatible and must be used in non-magnetic environments. The model number 12237 identifies this specific variant, and its use is authorized under FDA 510(k) clearance K011096, granted as Substantially Equivalent to a predicate device. Storage and handling must comply with manufacturer guidelines to maintain sterility and functionality.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK011096 | Date1 May 2001 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
-
- Terminated Z-1483-2014
Broken door assemblies on the Hospira/Abbott Acclaim Encore infusion pumps. If the door assembly breaks, it may prevent the door from closing properly and unrestricted flow may occur. If the door cannot be closed, the pump cannot be used which can result in a delay in therapy.
-
- Terminated Z-0012-2010
Fire/Shock hazard-- A component used in the device may cause sparks/flashes and poses a fire and shock hazard.
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
Other devices from Abbott Laboratories
Questions
What clinical settings is the Abbott Acclaim Encore, Model 12237, intended for use in, and why is this important?
The Abbott Acclaim Encore, Model 12237, is specifically intended for use in general hospitals, as indicated by its FDA classification under product code FRN and advisory committee designation. This is important because it ensures the device meets regulatory standards tailored for controlled, programmable intravenous fluid, medication, or nutrient delivery in hospital environments where precise dosing is critical for patient safety.
Is the Abbott Acclaim Encore, Model 12237, designed for reuse, or is it meant for single-use only? How does this affect its handling?
The device is explicitly designed for single-use only, as stated in the description. This means it must not be reused after a single patient administration to maintain sterility and prevent contamination. Proper disposal after use is required, and handling must comply with manufacturer guidelines to avoid compromising its sterile condition.
Can the Abbott Acclaim Encore, Model 12237, be used in an MRI environment, or are there specific environmental restrictions?
No, the device is not MRI-compatible and must be used in non-magnetic environments only. This restriction is critical to avoid interference with the pump’s functionality or potential safety hazards during MRI procedures, as magnetic fields could disrupt its operation.
How is the sterility of the Abbott Acclaim Encore, Model 12237, maintained, and what does this mean for storage and handling?
The device is supplied sterile and must be stored and handled according to the manufacturer’s guidelines to preserve sterility and functionality. This includes proper packaging, environmental controls, and adherence to sterile procedures during setup and use to ensure patient safety and device efficacy.
What regulatory pathway was followed for the FDA clearance of the Abbott Acclaim Encore, Model 12237, and what does this mean for its intended use?
The device received FDA 510(k) clearance (K011096) under the Substantially Equivalent classification, meaning it was deemed comparable to a predicate device already on the market. This clearance confirms its compliance with FDA regulations for infusion pumps in general hospitals, ensuring it meets safety and performance standards for controlled intravenous administration.