# K982672: Colleague Pump Syringe Adapter Set

- Pathway: 510(k) (Traditional)
- Applicant: Baxter Healthcare Corp
- Decided: Sep 4, 1998 after 35 days
- Product code: FPA (Set, Administration, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Baxter Solution Set with Microbore Tubing: named in the summary without a submission number
- (no number) Imed Vented Gemini® Syringe Set: named in the summary without a submission number

## Recalls of this device
- Jul 16, 2003 · Not classified · Z-1164-03: There are possible pinholes or perforations in the set tubing, caused by damage that occurred during the packaging process.

## Indications for use
The Colleague® Pump Syringe Adapter Set will be used to administer fluids from a container to a patient’s vascular system using an electronic infusion device.

Source page: https://510kreport.com/device/K982672
Methodology: https://510kreport.com/methodology