Vented Vial Adapter Transfer Device - 13mm
FDA 510(k) K160503 · Medimop Medical Projects, Ltd.
510(k) numberK160503
Submission
- Device name
- Vented Vial Adapter Transfer Device - 13mm
- Applicant
- Medimop Medical Projects, Ltd.
Ra'Anana, IL - Received
- February 24, 2016
- Decision date
- May 4, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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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|---|---|---|---|
| K252987 | ADRx Admixture DeviceLHI · Traditional | Epic Medical Pte. , Ltd. | 06/12/2026SE |
| K260301 | Vial AdapterLHI · Traditional | Hangzhou Qiantang Longyue Biotechnology Co., Ltd. | 06/05/2026SE |
| K250345 | Medline Bag DecanterLHI · Traditional | Medline Industries, LP | 10/24/2025SE |
| K251715 | FlowArt® Vial Access Device VentedLHI · Traditional | Asset Medikal | 10/14/2025SE |
| 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 |
More from Sfm Medical Devices GmbH
| 510(k) | Device | Decision |
|---|---|---|
| K140730 | VIAL2BAG Direct ConnectLHI · Traditional | 06/12/2014SE |
| K130179 | MP Vial Adapter 13MMLHI · Traditional | 08/08/2013SE |
| K132040 | Vial Connector 13MM Closed CollarLHI · Special | 07/31/2013SE |
| K122023 | Mixject with Spray HeadFMF · Traditional | 10/04/2012SE |
| K072759 | VIAL2BAGLHI · Abbreviated | 12/13/2007SE |
| K072511 | Swabable Vial Adapter 13MM, Swabable Vial Adapter 20MMLHI · Abbreviated | 12/13/2007SE |
| K062482 | Vented Vial Adapter Transfer DeviceLHI · Traditional | 11/03/2006SE |
| K031861 | MIX2VIAL Transfer DeviceLHI · Traditional | 07/29/2003SE |
| K001831 | Needleless Transfer DeviceLHI · Traditional | 07/11/2000SE |
| K001293 | Modification to Mixject Dispensing Pin/With Detachable Vial Holder/With Detachable Vial…LHI · Special | 05/05/2000SE |
Questions and answers
When was Vented Vial Adapter Transfer Device - 13mm cleared by the FDA?
Vented Vial Adapter Transfer Device - 13mm (K160503) received a 510(k) decision of Substantially Equivalent on May 4, 2016, 70 days after the submission was received.
What is the product code of K160503?
The FDA product code is LHI – Set, I.V. Fluid Transfer, a Class II (moderate risk) device regulated under 21 CFR 880.5440.