LHI — Set, I.V. Fluid Transfer Class II
FDA product code LHI covers "Set, I.V. Fluid Transfer", a Class II medical device regulated under 21 CFR 880.5440. Submissions are reviewed by the General Hospital panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- LHI
- Device Class
- Class II
- Regulation Number
- 880.5440
- Submission Type
- Review Panel
- HO
- Medical Specialty
- General Hospital
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K252987 | epic medical pte. | ADRx Admixture Device | June 12, 2026 |
| K260301 | hangzhou qiantang longyue biotechnology co | Vial Adapter | June 5, 2026 |
| K250345 | medline industries | Medline Bag Decanter | October 24, 2025 |
| K251715 | asset medikal | FlowArt® Vial Access Device Vented | October 14, 2025 |
| K251676 | microtek medical | Medline Microtek C-Flo Bag Decanter, Sterile (2000S); Medline Microtek Bag Decan | September 16, 2025 |
| K243404 | takeda pharmaceuticals | HyHub and HyHub Duo Vial Access Devices | July 18, 2025 |
| K240761 | yukon medical | Arisure® Closed Male Luer with Spike Adapter (YM060) | March 21, 2025 |
| K243985 | icu medical | Rio Drug Reconstitution Transfer Device | January 22, 2025 |
| K243486 | yukon medical | SmartSiteTM Vented Vial Access Device | December 6, 2024 |
| K241976 | sfm medical devices | nextaro® va, 15mm, 5µm | September 6, 2024 |
| K233287 | hangzhou qiantang longyue biotechnology co | Vent Vial Adapter | July 26, 2024 |
| K232987 | asset medikal tasarim sanayi ve ticaret a.s | FlowArt Valve for Vial Access | June 26, 2024 |
| K240940 | west pharmaceutical services | Vial2Bag Advanced® 20mm Admixture Device | May 3, 2024 |
| K233284 | hangzhou qiantang longyue biotechnology co | Vial Adapter with Filter | May 1, 2024 |
| K240748 | sfm medical devices | nextaro® v, 20/20 | April 16, 2024 |
| K233021 | care fusion | BD SmartSite 13mm Vial Access Device; BD SmartSite 20mm Vial Access Device | March 6, 2024 |
| K231071 | west pharma. services il | Mix2Vial® Transfer Device | January 19, 2024 |
| K232875 | west pharma. services il | Vial Adapter 20mm | December 14, 2023 |
| K230988 | west pharma. services il | Vial2Bag Advanced® 13mm Admixture Device | December 1, 2023 |
| K232055 | shanghai lingfu technology co | Vial Adapter | October 6, 2023 |