Fleboset Double
FDA 510(k) K102590 · Laboratorios Grifols, S.A.
510(k) numberK102590
Submission
- Device name
- Fleboset Double
- Applicant
- Laboratorios Grifols, S.A.
Parets Del Valles, Barcelona, ES - Received
- September 9, 2010
- Decision date
- January 13, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 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
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 |
|---|---|---|
| K162216 | Gri-Fill Peristaltic SetLHI · Abbreviated | 10/19/2017SE |
| K093182 | Set Gri-Fill 3.0LHI · Abbreviated | 01/27/2010SE |
| K082752 | QuickpinLHI · Traditional | 09/29/2008SE |
| K050339 | Set Gri-Fill 3.0-1 Way, 2 Ways, MultipleLHI · Traditional | 02/25/2005SE |
| K040456 | Fleboset MultipleLHI · Traditional | 03/09/2004SE |
| K033916 | Gri-Bag, Gri-Bag ApKPE · Traditional | 12/30/2003SE |
| K033682 | Set Gri-Fill 2.0-1 Way; 2.0-2 Ways; Luer Connection TubeLHI · Traditional | 12/17/2003SE |
| K031419 | Gri-Flex, Models 1000ML, 500ML, 250ML, 100MLKPE · Traditional | 11/24/2003SE |
Questions and answers
When was Fleboset Double cleared by the FDA?
Fleboset Double (K102590) received a 510(k) decision of Substantially Equivalent on January 13, 2011, 126 days after the submission was received.
What is the product code of K102590?
The FDA product code is LHI – Set, I.V. Fluid Transfer, a Class II (moderate risk) device regulated under 21 CFR 880.5440.