# K131517: Medrad Twist & GO High Pressure Connector Tubing

- Pathway: 510(k) (Special)
- Applicant: Medrad, Inc. / Bayer Medical Care, Inc.
- Decided: Aug 2, 2013 after 66 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: 1 generation back to K810924 (1981). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K810924: Medrad High Pressure Conecting Tube, Medrad, Inc. (1981) Summary page 1.

## Indications for use
The Twist & Go High Pressure Connector Tubing is intended to be used in the delivery of contrast media and common flushing solutions. The device is indicated for single use only with MEDRAD injectors.

Source page: https://510kreport.com/device/K131517
Methodology: https://510kreport.com/methodology