# K011096: Abbott Acclaim Encore, Model 12237

- Pathway: 510(k) (Special)
- Applicant: Abbott Laboratories
- Decided: May 1, 2001 after 21 days
- Product code: FRN (Pump, Infusion)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: 2 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
1 of 1 device in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Recalls of this device
- Oct 31, 2013 · Class I · 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 cann
- Aug 11, 2009 · Not classified · Z-0012-2010: Fire/Shock hazard-- A component used in the device may cause sparks/flashes and poses a fire and shock hazard.

Source page: https://510kreport.com/device/K011096
Methodology: https://510kreport.com/methodology