# K172631: Arisure Dry Spike

- Pathway: 510(k) (Traditional)
- Applicant: Yukon Medical
- Decided: Sep 29, 2017 after 28 days
- Product code: LHI (Set, I.V. Fluid Transfer)
- 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: 5 generations back to K883614 (1988). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110023: Infusion Adapter C100, Carmel Pharma Ab. (2011) Summary page 5.

## Indications for use
The Arisure™ Dry Spike allows for the addition of liquid medications to IV containers through a needle-free access port, and serves as a connector between an IV container and a standard IV set, while minimizing exposure to drug aerosols and spills.

Source page: https://510kreport.com/device/K172631
Methodology: https://510kreport.com/methodology