Transfer Set
FDA 510(k) K860595 · Migada, Ltd.
510(k) numberK860595
Submission
- Device name
- Transfer Set
- Applicant
- Migada, Ltd.
Israel, IL - Received
- February 19, 1986
- Decision date
- April 7, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LHI – Set, I.V. Fluid Transfer
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5440
- Specialty
- General Hospital
Other 510(k)s with product code LHI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
|---|---|---|
| K954883 | Free Flow Safety DeviceFPA · Traditional | 04/23/1996SE |
| K943095 | IV Transfer SpikeLHI · Traditional | 09/30/1994SE |
| K933929 | Lab-Site(R) Safety CannulaCBF · Traditional | 12/07/1993SE |
| K902881 | Lab-Site Safety NeedleCBT · Traditional | 09/26/1990SE |
| K870016 | Arterial Blood Gassing Monitoring System (Abg)DTB · Traditional | 05/28/1987SE |
| K864453 | Emergency & Military Infusion SystemFPA · Traditional | 01/20/1987SE |
| K863304 | Preselected Flow Rate I.V. SetFPA · Traditional | 12/09/1986SE |
| K860952 | I.V. Set with and Without Air VentFPA · Traditional | 08/27/1986SE |
| K861275 | High Flow I.V. SetFPA · Traditional | 06/02/1986SE |
| K860605 | Filter Set 1) 1.2 Mic Filter 2) 3.0 Mic FilterFPA · Traditional | 03/24/1986SE |
Questions and answers
When was Transfer Set cleared by the FDA?
Transfer Set (K860595) received a 510(k) decision of Substantially Equivalent on April 7, 1986, 47 days after the submission was received.
What is the product code of K860595?
The FDA product code is LHI – Set, I.V. Fluid Transfer, a Class II (moderate risk) device regulated under 21 CFR 880.5440.