# K063114: Disposable Transfer Sets with and Without Swabbable Valves and/or Check Valves

- Pathway: 510(k) (Abbreviated)
- Applicant: Coeur, Inc.
- Decided: Feb 9, 2007 after 121 days
- Product code: FPK (Tubing, Fluid Delivery)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K903493 (1991). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031808: Medrad Swabbable Valve Transfer Set, Medrad, Inc. (2003)
- K022431: Medrad Transfer Set, Medrad, Inc. (2002) Summary page 1.
- K961794: Fluid Administration Set - Contrast Manager, Merit Medical Systems, Inc. (1996) Summary page 1.
- K041178: Empower Transfer Set, (Cat. NO. 7725), E-Z-Em, Inc. (2004) Summary page 1.

## Cited in the summary but kept off the family tree
- K073597: Fill Tube - Coeur. Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
for use in transferring contrast, saline, or other diagnostic fluids between bulk containers and a syringe

Source page: https://510kreport.com/device/K063114
Methodology: https://510kreport.com/methodology