Data / Medical devices / United States / Yukon Medical, LLC
Yukon Medical, LLC: FDA-registered device maker in Durham, NC, United States, 11 510(k) clearances
Yukon Medical, LLC is registered with the FDA (registration 3009631669) in Durham, NC, United States. It lists 4 device types. The FDA files 11 510(k) clearances under its listings, the newest dated March 21, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3009631669
- Address
- 4021 Stirrup Creek Dr Ste 200, Durham, NC, United States, 27703
- Owner or operator
- Yukon Medical, LLC (10041722)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- August 23, 2012
- Registered through
- 2026
- Brand names listed
- Arisure Closed System Drug Transfer Device (CSTD), ClearTip Swab Contoured, ClearTip Swab Contoured Mini, ClearTip Swab Contoured Mini NB, ClearTip Ultra Thin Swab
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Applicator, Absorbent Tipped, Sterile | KXG | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System | ONB | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Set, Administration, Intravascular | FPA | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Set, I.V. Fluid Transfer | LHI | 2 | Complaint file establishment, Manufacturer, Specification developer | 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 |
|---|---|---|---|---|---|---|
| March 21, 2025 | K240761 | Arisure® Closed Male Luer with Spike Adapter (YM060) | LHI | Substantially Equivalent | Yukon Medical, LLC | accessdata.fda.gov |
| December 6, 2024 | K243486 | SmartSiteTM Vented Vial Access Device | LHI | Substantially Equivalent | Yukon Medical, LLC | accessdata.fda.gov |
| March 2, 2021 | K201422 | Arisure Closed System Drug Transfer Device (CSTD) | ONB | Substantially Equivalent | Yukon Medical, LLC | accessdata.fda.gov |
| October 3, 2017 | K172884 | Arisure Closed Vial Adapter | LHI | Substantially Equivalent | Yukon Medical | accessdata.fda.gov |
| September 29, 2017 | K172631 | Arisure Dry Spike | LHI | Substantially Equivalent | Yukon Medical | accessdata.fda.gov |
| June 2, 2017 | K171101 | Closed Male Luer | FPA | Substantially Equivalent | Yukon Medical | accessdata.fda.gov |
| July 31, 2015 | K151963 | SmartSite Vented Vial Access Device | LHI | Substantially Equivalent | Yukon Medical, LLC | accessdata.fda.gov |
| October 4, 2013 | K132863 | SMARTSITE VIALSHIELD | LHI | Substantially Equivalent | Yukon Medical, LLC | accessdata.fda.gov |
| August 14, 2012 | K122265 | VIALOK SINGLE VIAL ACCESS DEVICE VENTED | LHI | Substantially Equivalent | Yukon Medical, LLC | accessdata.fda.gov |
| May 3, 2012 | K121182 | VIALOK NON-VENTED | LHI | Substantially Equivalent | Yukon Medical, LLC | accessdata.fda.gov |
| March 30, 2012 | K120799 | ARISURE NEUTRAL VALVE | FPA | Substantially Equivalent | Yukon Medical, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of Set, I.V. Fluid Transfer
- All makers of Applicator, Absorbent Tipped, Sterile
- All makers of Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System
- All makers of Set, Administration, Intravascular
Updated March 21, 2025. 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.