# K010567: Optiflow Catheter #5641190 Catheter Only #5643150 Catheter Kit #5631000 Catheterless Tray-Generic (Combined with Cathetr

- Pathway: 510(k) (Special)
- Applicant: C.R. Bard, Inc.
- Decided: Mar 28, 2001 after 30 days
- Product code: MSD (Catheter, Hemodialysis, Implanted)
- Device class: 2
- Regulation: 21 CFR 876.5540
- 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; 2 cite it directly.
0 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
- K030020: Hemosplit Long-Term Hemodialysis Catheter (2003), 12 descendants of its own
- K033294: Hemosplit XK, Hemosplit XK Catheter, 16FR X 42 CM, Kit;16FR X 19 CM, Kit with Microintroducer (2003), 10 descendants of its own
- K051748: Hemoglide Series and Hemoglide Star Series XK Long-Term Hemodialysis Catheters (2005), 8 descendants of its own
- K190527: GlidePath Long-Term Hemodialysis Catheters, HemoStar Long-Term Hemodialysis Catheters, HemoStar XK Long-Term Hemodialysis Catheters (2020), 5 descendants of its own
- K200627: GlidePath 10F Long-Term Dialysis Catheter (2020), 2 descendants of its own

Source page: https://510kreport.com/device/K010567
Methodology: https://510kreport.com/methodology