# K801355: Bionics BI-Flo Stretch (Double Lumen for

- Pathway: 510(k) (Traditional)
- Applicant: Cordis Corp.
- Decided: Jul 8, 1980 after 29 days
- Product code: KOC (Accessories, Blood Circuit, Hemodialysis)
- Device class: 2
- Regulation: 21 CFR 876.5820
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 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
- K134019: Medisystems Onesite Dual Lumen Needle with Masterguard Anti-Stick Needle Protector, Medisystems Onesite Dual Lumen Butto (2014), 0 descendants of its own

Source page: https://510kreport.com/device/K801355
Methodology: https://510kreport.com/methodology