# K952799: Abbott XL3M Infusion Pump

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Jan 18, 1996 after 213 days
- Product code: FRN (Pump, Infusion)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: 6 (0 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.
0 of 1 device in its family (counting itself) have 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
- Jan 24, 2014 · Class II · Z-1704-2014: There is the potential for the door roller assembly on the Plum LifeCare 5000 Series and Plum XL families of infusers to break. In the event of a broken door roller pin, the door cannot appropriately 
- Feb 14, 2011 · Not classified · Z-1602-2011: Hospira has received reports of the Plum XL, XLM and XLD Infusion Pumps with no audible alarm at the low audio level setting.
- Feb 14, 2011 · Not classified · Z-1598-2011: Hospira has received reports of the Plum XL, XLM and XLD Infusion Pumps with no audible alarm at the low audio level setting.
- Feb 14, 2011 · Not classified · Z-1601-2011: Hospira has received reports of the Plum XL, XLM and XLD Infusion Pumps with no audible alarm at the low audio level setting.
- Aug 11, 2009 · Not classified · Z-0033-2010: Fire/Shock hazard-- A component used in the device may cause sparks/flashes and poses a fire and shock hazard.
- Aug 11, 2009 · Not classified · Z-0032-2010: 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/K952799
Methodology: https://510kreport.com/methodology