LHI — Set, I.V. Fluid Transfer Class II
FDA Device Classification
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 |
|---|
| 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 |
| K230464 | west pharma services il | MixJect® Transfer Device | May 22, 2023 |
| K222718 | hangzhou qiantang longyue biotechnology co | Vial Adapter | March 10, 2023 |