Data / Medical devices / United States / Kurin, Inc.
Kurin, Inc.: FDA-registered device maker in San Diego, CA, United States, 4 510(k) clearances
Kurin, Inc. is registered with the FDA (registration 3013696225) in San Diego, CA, United States. It lists 2 device types. The FDA files 4 510(k) clearances under its listings, the newest dated April 28, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3013696225
- Address
- 10840 Thornmint Road Suite 111, San Diego, CA, United States, 92127
- Owner or operator
- Kurin, Inc. (10057862)
- Roles
- Manufacturer
- First device listed
- June 4, 2018
- Registered through
- 2026
- Brand names listed
- Kurin Blood Collection Set w/ Jet Lock (w/o extension set) - DJ-PIV12/MJ-PIV12/TJ-PIV12/SJ-PIV10, Kurin Blood Collection Set w/ Jet Lock Tech (Venipuncture/Push-Button) - DJ-221/DJ-223/MJ-221/MJ-223/TJ-221/TJ-223, Kurin Blood Collection Set w/ Jet Lock Tech (Venipuncture/Slide)-DJ-121/DJ-123/MJ-121/MJ-123/TJ-121/TJ-123, Kurin Blood Collection Set w/ Jet Lock Tech (w/ extension set) - DJ-PIV18/MJ-PIV18/TJ-PIV18/SJ-PIV10, Kurin Blood Collection Set w/ Jet Lock Tech (w/o extension set) - DJ-PIV12/MJ-PIV12/TJ-PIV12/SJ-PIV4, Kurin Blood Collection Set w/ Jet Lock Tech - DJ-121/DJ-123/MJ-121/MJ-123/TJ-121/TJ-123, Kurin Blood Collection Set w/ Jet Lock Tech - DJ-221/DJ-223/MJ-221/MJ-223/TJ-221/TJ-223, Kurin Blood Collection Set w/ Kurin Lock Tech (Venipuncture/Push-Button) - D-21221/D-21223/M-21221/M-21223/T-21221/T-212 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Set, Administration, Intravascular | FPA | 2 | Manufacturer | accessdata.fda.gov |
| Tubes, Vials, Systems, Serum Separators, Blood Collection | JKA | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 28, 2023 | K220677 | Kurin Blood Culture Collection Set with Kurin Lock Technology | JKA | Substantially Equivalent | Kurin, Inc. | accessdata.fda.gov |
| February 4, 2020 | 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) | JKA | Substantially Equivalent | Kurin, Inc. | accessdata.fda.gov |
| January 18, 2019 | K181895 | Kurin PIV Blood Collection Set with High Pressure | JKA | Substantially Equivalent | Kurin, Inc. | accessdata.fda.gov |
| December 23, 2016 | K162233 | Kurin Blood Culture Collection Set | JKA | Substantially Equivalent | Pathway, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of Tubes, Vials, Systems, Serum Separators, Blood Collection
- All makers of Set, Administration, Intravascular
Updated April 28, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.