# K181895: Kurin PIV Blood Collection Set with High Pressure

- Pathway: 510(k) (Traditional)
- Applicant: Kurin, Inc.
- Decided: Jan 18, 2019 after 186 days
- Product code: JKA (Tubes, Vials, Systems, Serum Separators, Blood Collection)
- Device class: 2
- Regulation: 21 CFR 862.1675
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K970259 (1997). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092382: Nexus Pressure Rated Extension Sets, Nexus Medical, LLC (2010) Summary page 5.
- K162233: Kurin Blood Culture Collection Set, Pathway, LLC (2016) Summary page 5.

## Indications for use
Intended to connect to short peripheral catheter to obtain initial blood draw and when disconnected from the blood collection portion of the device, the pressure-rated extension set is intended to be utilized with infusions systems to administer IV fluids, medications, blood and blood products to the patient’s vascular system and may be safety used with power injectors at pressures up to 325 psi.

Source page: https://510kreport.com/device/K181895
Methodology: https://510kreport.com/methodology