SmartSiteTM Vented Vial Access Device
FDA 510(k) K243486 · Yukon Medical, LLC
510(k) numberK243486
Submission
- Device name
- SmartSiteTM Vented Vial Access Device
- Applicant
- Yukon Medical, LLC
Durham, NC, US - Received
- November 8, 2024
- Decision date
- December 6, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
Device classification
- Product code
- LHI – Set, I.V. Fluid Transfer
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5440
- Specialty
- General Hospital
Other 510(k)s with product code LHI
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|---|---|---|---|
| K252987 | ADRx Admixture DeviceLHI · Traditional | Epic Medical Pte. , Ltd. | 06/12/2026SE |
| K260301 | Vial AdapterLHI · Traditional | Hangzhou Qiantang Longyue Biotechnology Co., Ltd. | 06/05/2026SE |
| K250345 | Medline Bag DecanterLHI · Traditional | Medline Industries, LP | 10/24/2025SE |
| K251715 | FlowArt® Vial Access Device VentedLHI · Traditional | Asset Medikal | 10/14/2025SE |
| K251676 | Medline Microtek C-Flo Bag Decanter, Sterile (2000S); Medline Microtek Bag Decanter II…LHI · Traditional | Microtek Medical, LLC | 09/16/2025SE |
| K243404 | HyHub and HyHub Duo Vial Access DevicesLHI · Traditional | Takeda Pharmaceuticals | 07/18/2025SE |
| K240761 | Arisure® Closed Male Luer with Spike Adapter (YM060)LHI · Traditional | Yukon Medical, LLC | 03/21/2025SE |
| K243985 | Rio Drug Reconstitution Transfer DeviceLHI · Traditional | Icu Medical, Inc. | 01/22/2025SE |
| K241976 | nextaro® va, 15mm, 5µmLHI · Special | Sfm Medical Devices GmbH | 09/06/2024SE |
| K233287 | Vent Vial AdapterLHI · Traditional | Hangzhou Qiantang Longyue Biotechnology Co., Ltd. | 07/26/2024SE |
More from Hangzhou Qiantang Longyue Biotechnology Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K240761 | Arisure® Closed Male Luer with Spike Adapter (YM060)LHI · Traditional | 03/21/2025SE |
| K201422 | Arisure Closed System Drug Transfer Device (CSTD)ONB · Traditional | 03/02/2021SE |
| K172884 | Arisure Closed Vial AdapterLHI · Traditional | 10/03/2017SE |
| K172631 | Arisure Dry SpikeLHI · Traditional | 09/29/2017SE |
| K171101 | Closed Male LuerFPA · Traditional | 06/02/2017SE |
| K151963 | SmartSite Vented Vial Access DeviceLHI · Traditional | 07/31/2015SE |
| K132863 | Smartsite VialshieldLHI · Traditional | 10/04/2013SE |
| K122265 | Vialok Single Vial Access Device VentedLHI · Traditional | 08/14/2012SE |
| K121182 | Vialok Non-VentedLHI · Traditional | 05/03/2012SE |
| K120799 | Arisure Neutral ValveFPA · Traditional | 03/30/2012SE |
Questions and answers
When was SmartSiteTM Vented Vial Access Device cleared by the FDA?
SmartSiteTM Vented Vial Access Device (K243486) received a 510(k) decision of Substantially Equivalent on December 6, 2024, 28 days after the submission was received.
What is the product code of K243486?
The FDA product code is LHI – Set, I.V. Fluid Transfer, a Class II (moderate risk) device regulated under 21 CFR 880.5440.