# K041697: Terumo Circuit Connectors

- Pathway: 510(k) (Traditional)
- Applicant: Terumo Cardiovascular Systems Corporation
- Decided: Aug 11, 2004 after 50 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: 1 generation back to K895753 (1989). 1 ancestor in all.
14 later devices descend from it; 3 cite it directly.
3 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K895753: Brevet Disposable Connectors, Brevet, Inc. (1989) Summary page 1.

## Most influential descendants
- K053025: Jostra HLM Tubing Set (2005), 12 descendants of its own
- K080592: HLM Tubing Set with Bioline Coating (2008), 8 descendants of its own
- K090533: HLM Tubing Set with Softline Coating (2009), 3 descendants of its own
- K200109: OXY-1 System (2020), 2 descendants of its own
- K102726: Cardiohelp System (2011), 2 descendants of its own

## Indications for use
The Terumo Circuit Connectors are intended to be used to interconnect tubing and other devices within a circuit during extra-corporeal bypass procedures. The devices can be used in procedures lasting up to 6 hours in duration.

Source page: https://510kreport.com/device/K041697
Methodology: https://510kreport.com/methodology