LHI
- Product code
- LHI
- Device name
- Set, I.V. Fluid Transfer
- Device class
- Class 2
- 21 CFR
- 21 CFR 880.5440
- Medical specialty
- General Hospital
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 20
- Summaries archived here
- 17 (direct download)
- 510(k) clearances (all years, FDA)
- 206 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (20)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K252987 | 2026-06-12 | Epic Medical Pte. , Ltd. | ADRx Admixture Device | |
| K260301 | 2026-06-05 | Hangzhou Qiantang Longyue Biotechnolog… | Vial Adapter | |
| K250345 | 2025-10-24 | Medline Industries, LP | Medline Bag Decanter | |
| K251715 | 2025-10-14 | Asset Medikal | FlowArt® Vial Access Device Vented | — |
| K251676 | 2025-09-16 | Microtek Medical, LLC | Medline Microtek C-Flo Bag Decanter, Sterile (2000S)… | |
| K243404 | 2025-07-18 | Takeda Pharmaceuticals | HyHub and HyHub Duo Vial Access Devices | |
| K240761 | 2025-03-21 | Yukon Medical, LLC | Arisure® Closed Male Luer with Spike Adapter (YM060) | |
| K243985 | 2025-01-22 | Icu Medical, Inc. | Rio Drug Reconstitution Transfer Device | |
| K243486 | 2024-12-06 | Yukon Medical, LLC | SmartSiteTM Vented Vial Access Device | |
| K241976 | 2024-09-06 | Sfm Medical Devices GmbH | nextaro® va, 15mm, 5µm | |
| K233287 | 2024-07-26 | Hangzhou Qiantang Longyue Biotechnolog… | Vent Vial Adapter | |
| K232987 | 2024-06-26 | Asset Medikal Tasarim Sanayi VE Ticare… | FlowArt Valve for Vial Access | — |
| K240940 | 2024-05-03 | West Pharmaceutical Services, Inc. | Vial2Bag Advanced® 20mm Admixture Device | FDA |
| K233284 | 2024-05-01 | Hangzhou Qiantang Longyue Biotechnolog… | Vial Adapter with Filter | |
| K240748 | 2024-04-16 | Sfm Medical Devices GmbH | nextaro® v, 20/20 | |
| K233021 | 2024-03-06 | Care Fusion | BD SmartSite 13mm Vial Access Device; BD SmartSite… | |
| K231071 | 2024-01-19 | West Pharma. Services IL, Ltd. | Mix2Vial® Transfer Device | |
| K232875 | 2023-12-14 | West Pharma. Services IL, Ltd. | Vial Adapter 20mm | |
| K230988 | 2023-12-01 | West Pharma. Services IL, Ltd. | Vial2Bag Advanced® 13mm Admixture Device | |
| K232055 | 2023-10-06 | Shanghai Lingfu Technology Co., Ltd. | Vial Adapter |
Official FDA classification page: LHI
Classification and pathway per current FDA publications. Data from openFDA (CC0).