# K961703: Colleague 2 Volumetric Infusion Pump (Dual Channel)/Colleague 3 Volumetric Infusion Pump (Tree Channel)

- Pathway: 510(k) (Traditional)
- Applicant: Baxter Healthcare Corp
- Decided: Jul 8, 1996 after 67 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
Longest line of descent: 1 generation back to K915522 (1992). 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)
- K953098: Volumetric Infusion Pump, Baxter Healthcare Corp (1995) Summary page 2.
- K915522: Flo-Gard (R) 6201, Baxter Healthcare Corp (1992) Summary page 2.

## Recalls of this device
- Nov 4, 2004 · Not classified · Z-0343-05: 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-0880-04: 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.

## Indications for use
The Baxter Colleague™ 2 and 3 Volumetric Infusion Pumps are designed to meet the fluid delivery needs of today’s evolving health care environment. The pump can be utilized for continuous or intermittent delivery through clinically acceptable routes of administration such as intravenous (I'V), intra-arterial (1A), subcutaneous, epidural or irrigation of fluid spaces applications. Fluid delivery applications include: = parenteral fluids, drugs and electrolytes (e.g. cardiovascular drugs, antibiotics, anesthetics, analgesics, chemotherapy agents, total parenteral nutrition products, lipids, solutions for irrigation procedures, etc.); and * whole blood and blood products.

Source page: https://510kreport.com/device/K961703
Methodology: https://510kreport.com/methodology