# K993387: Ipump Pain Management System, Model 2L3107K

- Pathway: 510(k) (Special)
- Applicant: Baxter Healthcare Corp
- Decided: Nov 1, 1999 after 24 days
- Product code: FRN (Pump, Infusion)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K926385 (1994). 1 ancestor in all.
3 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K926385: Bard Apii Pump, C.R. Bard, Inc. (1994) Summary page 1.

## Most influential descendants
- K052973: Ipump Pain Management System, Model 2L3107, 2L3107K (2007), 2 descendants of its own
- K120209: Patient Controlled Analgesia (Pca) Button Cable (2012), 1 descendant of its own
- K220695: Elite Biomedical Solutions Dose Request Cord (2022), 0 descendants of its own

## Recalls of this device
- Dec 21, 2005 · Not classified · Z-0551-06: Delivery of unrequested PCA doses of medication due to damaged PCA cords, partial sticking of PCA button, and fluid ingress into the pump or PCA button.
- Oct 27, 2005 · Not classified · Z-0549-06: When infusing at flow rates below 0.5 mL/hr, the upstream occlusion alarm of the pumps may not detect the occlusion.
- Feb 10, 2005 · Not classified · Z-0130-06: Potential failures of the pump due to upstream occlusion alarms, electro-static discharge, system error 32 or 33, history printout errors and fluid volume in 'Use Previous Rx' when priming through the

## Indications for use
The Ipump™ Pain Management System is indicated for the controlled rate delivery of small volume parenteral fluids as prescribed by a physician. Delivery may be continuous or intermittent and may be epidural, intravenous or subcutaneous.

Source page: https://510kreport.com/device/K993387
Methodology: https://510kreport.com/methodology