# K022918: Adapters with X-Coating

- Pathway: 510(k) (Traditional)
- Applicant: Terumo Cardiovascular Systems Corporation
- Decided: Nov 27, 2002 after 84 days
- Product code: DTL (Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4290
- 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) uncoated adapters: named in the summary without a submission number

## Indications for use
The Adapters with X-Coating are intended to be used to interconnect tubing and other devices within a circuit during extracorporeal bypass procedures. The adapters are intended for use in procedures lasting up to 6-hours in duration. The blood-contacting surfaces of the adapters are coated with X-Coating, which is a biocompatible coating that reduces the adhesion of platelets to the surfaces.

Source page: https://510kreport.com/device/K022918
Methodology: https://510kreport.com/methodology