# K031808: Medrad Swabbable Valve Transfer Set

- Pathway: 510(k) (Special)
- Applicant: Medrad, Inc.
- Decided: Jul 11, 2003 after 29 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: 3 generations back to K903493 (1991). 3 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022431: Medrad Transfer Set, Medrad, Inc. (2002)

## Most influential descendants
- K102073: Med-RX Transfer Set, Models 10-1227TS, 10-1300TS, 10-1305TS and 10-1306TS (2010), 0 descendants of its own
- K063114: Disposable Transfer Sets with and Without Swabbable Valves and/or Check Valves (2007), 0 descendants of its own

## Indications for use
The Medrad Swabbable Valve Transfer Set (SVTS) is intended to be used in the delivery of contrast media and saline into a syringe. The SVTS is a needle-free system. Use of a needle-free system may aid in the prevention of needle-stick injuries.

Source page: https://510kreport.com/device/K031808
Methodology: https://510kreport.com/methodology