# K093992: Terumo Lauer Lock Adapter

- Pathway: 510(k) (Traditional)
- Applicant: Terumo Cardiovascular Systems Corporation
- Decided: May 19, 2010 after 146 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
Longest line of descent: 2 generations back to K790563 (1979). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992906: Components for Cardiovascular Procedure Kit, Olson Medical Sales, Inc. (1999) Summary page 2.

## Indications for use
The Terumo Luer Lock Adapters are single use, disposable components, intended to be used to interconnect tubing and other devices during cardiopulmanary bypass pracedures. The devices may be used in.procedures lasting up to 6 hours in duration.

Source page: https://510kreport.com/device/K093992
Methodology: https://510kreport.com/methodology
