# K771692: Tubing Sets

- Pathway: 510(k) (Traditional)
- Applicant: Cobe Laboratories, Inc.
- Decided: Oct 4, 1977 after 28 days
- Product code: DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4210
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
15 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)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## 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

Source page: https://510kreport.com/device/K771692
Methodology: https://510kreport.com/methodology