Smartsite Vented Vial Access Device, Model TBD
FDA 510(k) K052790 · Cardinal Health, Alaris Products
510(k) numberK052790
Submission
- Device name
- Smartsite Vented Vial Access Device, Model TBD
- Applicant
- Cardinal Health, Alaris Products
San Diego, CA, US - Received
- October 3, 2005
- Decision date
- December 23, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LHI – Set, I.V. Fluid Transfer
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5440
- Specialty
- General Hospital
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| K250345 | Medline Bag DecanterLHI · Traditional | Medline Industries, LP | 10/24/2025SE |
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| 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 |
| K243486 | SmartSiteTM Vented Vial Access DeviceLHI · Traditional | Yukon Medical, LLC | 12/06/2024SE |
| K241976 | nextaro® va, 15mm, 5µmLHI · Special | Sfm Medical Devices GmbH | 09/06/2024SE |
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| K051641 | Alaris System PC Unit, Model 8001FRN · Traditional | 10/20/2005SE |
| K050115 | Blood Hand Pump Administration SetBRZ · Traditional | 04/01/2005SE |
| K043590 | Se Infusion System with MMSFRN · Traditional | 03/25/2005SE |
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Questions and answers
When was Smartsite Vented Vial Access Device, Model TBD cleared by the FDA?
Smartsite Vented Vial Access Device, Model TBD (K052790) received a 510(k) decision of Substantially Equivalent on December 23, 2005, 81 days after the submission was received.
What is the product code of K052790?
The FDA product code is LHI – Set, I.V. Fluid Transfer, a Class II (moderate risk) device regulated under 21 CFR 880.5440.