# K150921: Orbit Infusion Set

- Pathway: 510(k) (Traditional)
- Applicant: Ypsomed AG
- Decided: Apr 12, 2016 after 372 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: 2 generations back to K033290 (2004). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130468: Orbit Infusion Set, Ypsomed AG (2013) Summary page 4.

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

Source page: https://510kreport.com/device/K150921
Methodology: https://510kreport.com/methodology