# Yukon Medical, LLC

- Location (FDA's records): Durham, NC
- FDA decisions: 11 (2012–2025): 11 510(k) clearances
- Names in FDA's records: Yukon Medical, LLC (8); Yukon Medical (3)
- Product codes: LHI (8), FPA (2), ONB (1)
- 510(k) review time since 2016: median 39 days, against 181 for FDA's reviews in the same codes and years (4 of 6 faster)
- Predicates its devices cite: 11 (4 its own); citations of its devices by later devices: 6 (4 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Cardinal Health, Alaris Products: 2 (https://510kreport.com/company/cardinal-health-alaris-products)
- Alaris Medical Systems, Inc.: 1 (https://510kreport.com/company/alaris-medical-systems)
- Icu Medical, Inc.: 1 (https://510kreport.com/company/icu-medical)
- Carmel Pharma Ab.: 1 (https://510kreport.com/company/carmel-pharma)
- Teva Medical Ltd., Migada Plant: 1 (https://510kreport.com/company/teva-medical-migada-plant)
- Medimop Medical Projects, Ltd.: 1 (https://510kreport.com/company/medimop-medical-projects)

## Firms that cite its devices most
- Cair Lgl: 1 (https://510kreport.com/company/cair-lgl)
- Epic Medical Pte., Ltd.: 1 (https://510kreport.com/company/epic-medical)

## Its most-cited devices
- K132863: Smartsite Vialshield (2013), cited by 1
- K121182: Vialok Non-Vented (2012), cited by 1
- K120799: Arisure Neutral Valve (2012), cited by 1
- K171101: Closed Male Luer (2017), cited by 1
- K151963: SmartSite Vented Vial Access Device (2015), cited by 1
- K201422: Arisure Closed System Drug Transfer Device (CSTD) (2021), cited by 1

## Recent decisions
- K240761: Arisure® Closed Male Luer with Spike Adapter (YM060) (Mar 21, 2025)
- K243486: SmartSiteTM Vented Vial Access Device (Dec 6, 2024)
- K201422: Arisure Closed System Drug Transfer Device (CSTD) (Mar 2, 2021)
- K172884: Arisure Closed Vial Adapter (Oct 3, 2017)
- K172631: Arisure Dry Spike (Sep 29, 2017)
- K171101: Closed Male Luer (Jun 2, 2017)
- K151963: SmartSite Vented Vial Access Device (Jul 31, 2015)
- K132863: Smartsite Vialshield (Oct 4, 2013)

Source page: https://510kreport.com/company/yukon-medical