Yukon Medical, LLC
Durham, NC, US
Yukon Medical, LLC appears in FDA device records in Durham, NC. FDA records list 11 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 11 510(k) clearances for Yukon Medical, LLC between 2012 and 2025. The busiest year on record is 2012, with 3. The most recent is 2025, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2012 | 3 |
| 2013 | 1 |
| 2015 | 1 |
| 2017 | 3 |
| 2021 | 1 |
| 2024 | 1 |
| 2025 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K240761 | Arisure® Closed Male Luer with Spike Adapter (YM060) | LHI | Substantially Equivalent | |
| K243486 | SmartSiteTM Vented Vial Access Device | LHI | Substantially Equivalent | |
| K201422 | Arisure Closed System Drug Transfer Device (CSTD) | ONB | Substantially Equivalent | |
| K172884 | Arisure Closed Vial Adapter | LHI | Substantially Equivalent | |
| K172631 | Arisure Dry Spike | LHI | Substantially Equivalent | |
| K171101 | Closed Male Luer | FPA | Substantially Equivalent | |
| K151963 | SmartSite Vented Vial Access Device | LHI | Substantially Equivalent | |
| K132863 | SMARTSITE VIALSHIELD | LHI | Substantially Equivalent | |
| K122265 | VIALOK SINGLE VIAL ACCESS DEVICE VENTED | LHI | Substantially Equivalent | |
| K121182 | VIALOK NON-VENTED | LHI | Substantially Equivalent | |
| K120799 | ARISURE NEUTRAL VALVE | FPA | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3009631669 | 3009631669 | Yukon Medical, LLC | 4021 Stirrup Creek Dr Ste 200, Durham, NC 27703 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain