Yukon Medical, LLC: FDA clearances and approvals
Yukon Medical, LLC has 11 FDA 510(k) clearances (first 2012, latest 2025), across 3 product codes in 1 review panel. Median 510(k) review time: 22 days. Since 2017 its median was 39 days, against 223 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 3 | 15 |
| 2013 | 1 | 22 |
| 2014 | 0 | — |
| 2015 | 1 | 15 |
| 2016 | 0 | — |
| 2017 | 3 | 28 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 1 | 277 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 1 | 28 |
| 2025 | 1 | 366 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Yukon Medical, LLC's cleared 510(k)s took a median 39 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 223 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LHI | Set, I.V. Fluid Transfer | 8 | 8 |
| FPA | Set, Administration, Intravascular | 2 | 2 |
| ONB | Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System | 1 | 1 |
Review panels
- General Hospital (11)
Most recent Yukon Medical, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K240761 | Arisure® Closed Male Luer with Spike Adapter (YM060) | LHI | 2025-03-21 | 366 |
| K243486 | SmartSiteTM Vented Vial Access Device | LHI | 2024-12-06 | 28 |
| K201422 | Arisure Closed System Drug Transfer Device (CSTD) | ONB | 2021-03-02 | 277 |
| K172884 | Arisure Closed Vial Adapter | LHI | 2017-10-03 | 12 |
| K172631 | Arisure Dry Spike | LHI | 2017-09-29 | 28 |
| K171101 | Closed Male Luer | FPA | 2017-06-02 | 50 |
| K151963 | SmartSite Vented Vial Access Device | LHI | 2015-07-31 | 15 |
| K132863 | SMARTSITE VIALSHIELD | LHI | 2013-10-04 | 22 |
| K122265 | VIALOK SINGLE VIAL ACCESS DEVICE VENTED | LHI | 2012-08-14 | 15 |
| K121182 | VIALOK NON-VENTED | LHI | 2012-05-03 | 15 |
1 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Yukon Medical, LLC.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Yukon Medical, LLC have?
Yukon Medical, LLC has 11 FDA 510(k) clearances (first 2012, latest 2025), across 3 product codes in 1 review panel.
How long does FDA take to clear Yukon Medical, LLC's 510(k)s?
The median time from FDA receipt to decision across Yukon Medical, LLC's cleared 510(k)s is 22 days. Since 2017: 39 days, versus 223 days for all cleared 510(k)s in the same product codes.
What devices does Yukon Medical, LLC make?
Its most frequent FDA product codes are LHI (Set, I.V. Fluid Transfer, 8); FPA (Set, Administration, Intravascular, 2); ONB (Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System, 1).
Has Yukon Medical, LLC had device recalls?
openFDA lists no recalls under a recalling firm name matching Yukon Medical, LLC. Related entities may recall under other names.
Next steps
- See all 11 Yukon Medical, LLC clearances with predicates and recalls
- Run predicate analysis for product code LHI, Yukon Medical, LLC's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.