Product code LHI
- Device name
- Set, I.V. Fluid Transfer
- Medical specialty
- General Hospital
- Device class
- 2
- Regulation number
- 880.5440
- Review panel
- HO
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K250345 | Medline Bag Decanter | Medline Industries, LP | 2025-10-24 |
| K251715 | FlowArt® Vial Access Device Vented | Asset Medikal | 2025-10-14 |
| K251676 | Medline Microtek C-Flo Bag Decanter, Sterile (2000S); Medline Microtek Bag Decanter II, Sterile (2002S); Medline Microtek Vial Decanter, Sterile (2006S); Medline Microtek Transfer Device, Sterile (2008S) | Microtek Medical, LLC | 2025-09-16 |
| K243404 | HyHub™ and HyHub™ Duo Vial Access Devices | Takeda Pharmaceuticals | 2025-07-18 |
| K240761 | Arisure® Closed Male Luer with Spike Adapter (YM060) | Yukon Medical, LLC | 2025-03-21 |
| K243985 | Rio™ Drug Reconstitution Transfer Device | Icu Medical, Inc. | 2025-01-22 |
| K243486 | SmartSiteTM Vented Vial Access Device | Yukon Medical, LLC | 2024-12-06 |
| K241976 | nextaro® va, 15mm, 5µm | Sfm Medical Devices GmbH | 2024-09-06 |
| K233287 | Vent Vial Adapter | Hangzhou Qiantang Longyue Biotechnology Co., Ltd. | 2024-07-26 |
| K232987 | FlowArt Valve for Vial Access | Asset Medikal Tasarim Sanayi VE Ticaret A.S. | 2024-06-26 |
| K240940 | Vial2Bag Advanced® 20mm Admixture Device | West Pharmaceutical Services, Inc. | 2024-05-03 |
| K233284 | Vial Adapter with Filter | Hangzhou Qiantang Longyue Biotechnology Co., Ltd. | 2024-05-01 |
| K240748 | nextaro® v, 20/20 | Sfm Medical Devices GmbH | 2024-04-16 |
| K233021 | BD SmartSite™ 13mm Vial Access Device; BD SmartSite™ 20mm Vial Access Device | Care Fusion | 2024-03-06 |
| K231071 | Mix2Vial® Transfer Device | West Pharma. Services IL, Ltd. | 2024-01-19 |
| K232875 | Vial Adapter 20mm | West Pharma. Services IL, Ltd. | 2023-12-14 |
| K230988 | Vial2Bag Advanced® 13mm Admixture Device | West Pharma. Services IL, Ltd. | 2023-12-01 |
| K232055 | Vial Adapter | Shanghai Lingfu Technology Co., Ltd. | 2023-10-06 |
| K230464 | MixJect® Transfer Device | West Pharma. Services IL, Ltd. | 2023-05-22 |
| K222718 | Vial Adapter | Hangzhou Qiantang Longyue Biotechnology Co., Ltd. | 2023-03-10 |
| K213513 | Vented Vial Adapter 20mm | West Pharma. Services IL, Ltd. | 2022-08-31 |
| K212525 | Advcare Vial Direct to Bag (VDB) Needle-free Admixture Devices | Advcare Medical | 2022-08-19 |
| K220856 | Vial Adapter Ø13mm | Avenir Performance Européenne Medical (Apem) | 2022-06-21 |
| K212445 | freeflex+ Transfer Adapter | Fresenius Kabi AG | 2022-06-01 |
| K212530 | IVX Fluid Transfer Set | Omnicell, Inc. | 2022-04-24 |
| K202732 | SOL-CARE IV Bag Safety Connector | Sol-Millennium Medical Group | 2021-11-03 |
| K203674 | B Dispensing Line | Aea Srl | 2021-09-27 |
| K200893 | ProntoPump Sterile Tube Set | Ipax, Inc. | 2021-05-04 |
| K201469 | Mini Spike Plus 6/8R | B.Braun Medical, Inc. | 2020-12-09 |
| K201415 | Vial2Bag Advanced 20mm Admixture Device | West Pharmaceutical Services Az, Inc. | 2020-10-21 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 07613203011495 | Alaris, SmartSite | BD Switzerland Sàrl | 2016-10-17 |
| 07613203010894 | Alaris, SmartSite | BD Switzerland Sàrl | 2016-10-17 |
| 07613203012379 | Alaris, SmartSite | BD Switzerland Sàrl | 2016-09-23 |
| 07613203011556 | Alaris, SmartSite | BD Switzerland Sàrl | 2016-09-23 |
| 00851891007070 | ViaLok | YUKON MEDICAL, LLC | 2016-09-23 |
| 07613203010399 | Alaris, SmartSite | BD Switzerland Sàrl | 2016-09-23 |
| 07613203011839 | Alaris, SmartSite | BD Switzerland Sàrl | 2016-09-22 |
| 07613203011532 | Alaris, SmartSite | BD Switzerland Sàrl | 2016-09-22 |
| 07613203011853 | Alaris, SmartSite | BD Switzerland Sàrl | 2016-09-22 |
| 07613203011877 | Alaris, SmartSite | BD Switzerland Sàrl | 2016-09-22 |
| 07613203011976 | Alaris, SmartSite | BD Switzerland Sàrl | 2016-09-22 |
| 07613203011990 | Alaris, SmartSite | BD Switzerland Sàrl | 2016-09-22 |
| 07613203012256 | Alaris, SmartSite | BD Switzerland Sàrl | 2016-09-22 |
| 07613203012270 | Alaris, SmartSite | BD Switzerland Sàrl | 2016-09-22 |
| 07613203012317 | Alaris, SmartSite | BD Switzerland Sàrl | 2016-09-22 |
| 07613203012331 | Alaris, SmartSite | BD Switzerland Sàrl | 2016-09-22 |
| 07613203012355 | Alaris, SmartSite | BD Switzerland Sàrl | 2016-09-22 |
| 07613203012393 | Alaris, SmartSite | BD Switzerland Sàrl | 2016-09-22 |
| 07613203011792 | Alaris, SmartSite | BD Switzerland Sàrl | 2016-09-22 |
| 07613203011518 | Alaris, SmartSite | BD Switzerland Sàrl | 2016-09-22 |
| 07613203011471 | Alaris, SmartSite | BD Switzerland Sàrl | 2016-09-22 |
| 07613203011358 | Alaris, SmartSite | BD Switzerland Sàrl | 2016-09-22 |
| 07613203011310 | SmartSite | BD Switzerland Sàrl | 2016-09-22 |
| 07613203010870 | BD SmartSite | BD Switzerland Sàrl | 2016-09-22 |
| 07613203010351 | Alaris, Signature Edition | BD Switzerland Sàrl | 2016-09-22 |
| 07613203010078 | Alaris | BD Switzerland Sàrl | 2016-09-22 |
| 07613203009652 | Alaris, SmartSite | BD Switzerland Sàrl | 2016-09-22 |
| 07613203009539 | Alaris | BD Switzerland Sàrl | 2016-09-22 |
| 07613203009454 | Alaris | BD Switzerland Sàrl | 2016-09-22 |
| 07613203009331 | Alaris, Signature Edition, SmartSite | BD Switzerland Sàrl | 2016-09-22 |