# K022857: Pump Tubing with X-Coating

- Pathway: 510(k) (Special)
- Applicant: Terumo Cardiovascular Systems Corporation
- Decided: Sep 19, 2002 after 22 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
Longest line of descent: 1 generation back to K993189 (2000). 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)
- K993189: Cardiopulmonary Bypass Pump Tubing - 1/4 Inch Tubing, Cardiopulmonary Bypass Pump Tubing - 3/8 Inch Tubing, Terumo Corp. (2000) Summary page 2.

## Indications for use
The Cardiopulmonary Bypass Pump Tubing with X-Coating is intended to provide a conduit for extracorporeal blood 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/K022857
Methodology: https://510kreport.com/methodology