# K003288: Origen Dual Lumen Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Origen Biomedical, Inc.
- Decided: Jun 8, 2001 after 231 days
- Product code: DQO (Catheter, Intravascular, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 870.1200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
44 later devices descend from it; 3 cite it directly.
0 of 45 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K081820: Avalon Elite BI-Caval Dual Lumen Catheter, 13FR, 16FR, 19FR, 20FR, 23FR, 27FR, 31FR (2008), 19 descendants of its own
- K031485: Rinspiration System (2003), 19 descendants of its own
- K041123: Rinspiration System,Rinspiration System Short Tip, Models FG01477/FG01703 (2004), 17 descendants of its own
- K041291: Rinspiration System (2004), 17 descendants of its own
- K050130: Kerberos Proximal Solutions Rispiration System (2005), 16 descendants of its own

Source page: https://510kreport.com/device/K003288
Methodology: https://510kreport.com/methodology