# K162233: Kurin Blood Culture Collection Set

- Pathway: 510(k) (Traditional)
- Applicant: Pathway, LLC
- Decided: Dec 23, 2016 after 137 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: 2 generations back to K970259 (1997). 3 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980414: Vacutainer Brand Safety-Lok Blood Collection Set Model Multiple, Vacutainer Brand Blood Collection Set, Bd Becton Dickinson Vacutainer Systems Preanalytic (1998) Summary page 4.
- K923090: Saf-T Holder Multi Sample Luer Adapter W/ Blood, Ryan Medical, Inc. (1992) Summary page 4.

## Most influential descendants
- K191832: Kurin Blood Culture Collection Set with Kurin Lock Technology, Push-Button Needle (Product models M-21221, M-21223, D-21221, D-21223, T-21221, T-21223) (2020), 0 descendants of its own
- K181895: Kurin PIV Blood Collection Set with High Pressure (2019), 0 descendants of its own

## Indications for use
The Kurin Blood Culture Collection Set is a winged blood collection needle with flexible tubing intended for venipuncture to obtain blood samples. It is provided with a safety shield for covering the used venipuncture needle prior to disposal to aid in the prevention of needlestick injury if manually activated after the blood draw. For blood collection, the set also includes a safety shield and apparatus for connection to vacuum based collection vials.

Source page: https://510kreport.com/device/K162233
Methodology: https://510kreport.com/methodology