# K010566: Colleague Volumetric Infusion Pump

- Pathway: 510(k) (Traditional)
- Applicant: Baxter Healthcare Corp
- Decided: May 15, 2001 after 78 days
- Product code: FRN (Pump, Infusion)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
9 later devices descend from it; 2 cite it directly.
1 of 10 devices in its family (counting itself) has a Class I recall.

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

## Most influential descendants
- K042228: Beeline Motiv, Propolis, Pca (2004), 7 descendants of its own
- K050770: Modification to Accufuser, Accufuser Plus Standard Procedure Kit (2005), 6 descendants of its own
- K052451: MPS Acacia Medflo Elastomeric Pump (2005), 5 descendants of its own
- K081905: Accuflow and Accuflux Elastomeric Infusion Pump (2008), 4 descendants of its own
- K151650: SMARTez elastomeric infusion pump (2016), 3 descendants of its own

## Recalls of this device
- Nov 4, 2004 · Not classified · Z-0342-05: A software anomaly causes a failure alarm code 12:303 which audibly alarms and stops the function of all channels in use. This causes an interruption in therapy, which may result in a risk to the pati
- Apr 13, 2004 · Not classified · Z-0879-04: Ink deterioration of the letters, numbers and symbols of the programming and pump channel keypads, which may impact the legibility of the keys over time.

Source page: https://510kreport.com/device/K010566
Methodology: https://510kreport.com/methodology