# K150542: Terumo Pump Tubing

- Pathway: 510(k) (Special)
- Applicant: Terumo Cardiovascular Systems Corporation
- Decided: May 1, 2015 after 59 days
- Product code: DWE (Tubing, Pump, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4390
- Recalls of this device: none
- 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) 70D PVC Pump Tubing 3/32” x 1/16” (Pre-Amendment): named in the summary without a submission number

## Indications for use
The Terumo® Pump Tubing is intended to provide a conduit for extracorporeal fluid flow through a roller pump during cardiopulmonary bypass procedures. The tubing is intended for use in procedures lasting up to 6-hours in duration.

Source page: https://510kreport.com/device/K150542
Methodology: https://510kreport.com/methodology