# K220677: Kurin Blood Culture Collection Set with Kurin Lock Technology

- Pathway: 510(k) (Traditional)
- Applicant: Kurin, Inc.
- Decided: Apr 28, 2023 after 416 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: 7 generations back to K970259 (1997). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200661: Steripath Micro Blood Collection System, Magnolia Medical Technologies, Inc. (2020) Summary page 4.

## Indications for use
The Kurin Blood Culture Collection Set is intended to obtain blood samples through the patient's vasculature via venipuncture or Peripheral IV (PIV) access. As it enters the Kurin Lock, blood initially fills a side channel then flows into the sample collection device (syringe or bottle) via an adjoining sampling channel to reduce blood culture contamination rates*. When supplied with a pressure-rated extension set, the pressure-rated extension set is intended to be utilized separately with infusions systems to administer IV fluids, medications, blood and blood products into the patient's vascular system and may be safely used with power injectors at pressures up to 325 psi. *The Kurin Blood Collection System is for use as a blood collection system and its Kurin Lock allows the specimen of blood from the patient to be sidelined prior to the collection of the test sample to reduce the frequency of blood culture contamination when contaminates are present in the initial blood sample compared to blood cultures drawn using standard practice without the Kurin Lock.

Source page: https://510kreport.com/device/K220677
Methodology: https://510kreport.com/methodology