# K010924: Modification to Plum XL Infusion Pump

- Pathway: 510(k) (Special)
- Applicant: Abbott Laboratories
- Decided: Apr 6, 2001 after 10 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.
14 later devices descend from it; 1 cites it directly.
4 of 15 devices 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.

## Most influential descendants
- K012383: Gemini PC-1,PC-2, PC-2TX,PC-4, Signature Edition Infusion Pump (SE), Medsystem Iii Infusion (Msiii), Medsystem Patient C (2001), 13 descendants of its own
- K050301: Mridium 3850 Mri Pump System (2005), 4 descendants of its own
- K133532: Alaris System with Guardrails Suite MX (2014), 3 descendants of its own
- K030136: Drip Alert (2003), 3 descendants of its own
- K090087: Mridium 3860 Mri Infusion Pump/Monitoring System (2009), 2 descendants of its own

## Recalls of this device
- Jan 24, 2014 · Class II · Z-1703-2014: 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-1599-2011: 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-0034-2010: 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-0030-2010: 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-0029-1010: 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-0031-2010: 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/K010924
Methodology: https://510kreport.com/methodology