# K003105: Biosphere Medical Infusion Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Biosphere Medical
- Decided: May 22, 2001 after 230 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.
31 later devices descend from it; 2 cite it directly.
0 of 32 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
- K041826: Ekos Ultrasound Infusion System (2005), 19 descendants of its own
- K051225: Ekos Micro-Infusion System (2005), 18 descendants of its own
- K053437: Ekos Micro-Infusion System (2006), 16 descendants of its own
- K053432: Ekos Micro-Infusion System (2005), 16 descendants of its own
- K062508: Neurowave Micro-Infusion System (2006), 14 descendants of its own

Source page: https://510kreport.com/device/K003105
Methodology: https://510kreport.com/methodology