# K130468: Orbit Infusion Set

- Pathway: 510(k) (Special)
- Applicant: Ypsomed AG
- Decided: Mar 19, 2013 after 22 days
- Product code: FPA (Set, Administration, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K033290 (2004). 1 ancestor in all.
5 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033290: Talon Infusion Set, Model IP XXXX, Icu Medical, Inc. (2004) Summary page 1.

## Most influential descendants
- K150059: BD FlowSmart Set (2015), 3 descendants of its own
- K153257: BD FlowSmart Set, MiniMed Pro-Set (2015), 2 descendants of its own
- K160651: BD FlowSmart Set, MiniMed Pro-Set (2016), 1 descendant of its own
- K181718: BD FlowSmart Set/MiniMed Pro-Set (2018), 0 descendants of its own
- K150921: Orbit Infusion Set (2016), 0 descendants of its own

## Indications for use
Orbit Infusion Sets ate intended for the subcutaneous delivery of fluids and medication, such as insulin, from an external infusion pump.

Source page: https://510kreport.com/device/K130468
Methodology: https://510kreport.com/methodology