# K070125: Colleague Guardian Configuration Tool; Colleague DL2 Event History Download Software Application

- Pathway: 510(k) (Traditional)
- Applicant: Baxter Healthcare Corp
- Decided: Apr 16, 2007 after 90 days
- Product code: FRN (Pump, Infusion)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K010566 (2001). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041191: Colleague Volumetric Infusion Pumps, Baxter Healthcare Corp (2004) Summary page 1.
- K010566: Colleague Volumetric Infusion Pump, Baxter Healthcare Corp (2001) Summary page 1.

## Indications for use
The COLLEAGUE GUARDIAN Configuration Tool is a proprietary, Personal Computer (PC) based software accessory that is used to define, create and maintain the COLLEAGUE Personality Feature Sets, Labels and rule sets (COLLEAGUE GUARDIAN Configurations) associated with the COLLEAGUE GUARDIAN feature. This software accessory can be utilized with product codes of the COLLEAGUE Volumetric Infusion Pump that contain the COLLEAGUE GUARDIAN feature. The COLLEAGUE DL2 Event History Download Software Application is a proprietary, Personal Computer (PC) based software accessory. It provides access to event history information from all product codes of the COLLEAGUE Volumetric Infusion Pump, which can then be downloaded, viewed, printed and copied to the Windows Clipboard for pasting into other programs.

Source page: https://510kreport.com/device/K070125
Methodology: https://510kreport.com/methodology