Injector Luer, Model N34, Injector Luer Lock, Model N35, Injector Luer Lock, N35C, Connector Luer Lock, Model C35,
FDA 510(k) K092782 · Carmel Pharma Ab.
510(k) numberK092782
Submission
- Device name
- Injector Luer, Model N34, Injector Luer Lock, Model N35, Injector Luer Lock, N35C, Connector Luer Lock, Model C35,
- Applicant
- Carmel Pharma Ab.
Molndal, SE - Received
- September 10, 2009
- Decision date
- December 7, 2009
- 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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|---|---|---|---|
| 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 |
|---|---|---|
| K110023 | Infusion Adapter C100LHI · Traditional | 04/12/2011SE |
| K090634 | Phaseal Protector P14, P21, P28 and P50LHI · Special | 03/23/2009SE |
| K060866 | Phaseal - Closed System for the Preparation and Administration of Parenteral DrugsLHI · Special | 04/28/2006SE |
| K023747 | PhasealLHI · Special | 11/15/2002SE |
| K001368 | Protector 21, Protector 50, Protector 14, Injector Luer Lock, Infusion AdapterLHI · Special | 05/12/2000SE |
| K980381 | Phaseal, Closed System Forhandling of Parenteral Drugs, Additional Administration…LHI · Traditional | 03/03/1998SE |
Questions and answers
When was Injector Luer, Model N34, Injector Luer Lock, Model N35, Injector Luer Lock, N35C, Connector Luer Lock, Model C35, cleared by the FDA?
Injector Luer, Model N34, Injector Luer Lock, Model N35, Injector Luer Lock, N35C, Connector Luer Lock, Model C35, (K092782) received a 510(k) decision of Substantially Equivalent on December 7, 2009, 88 days after the submission was received.
What is the product code of K092782?
The FDA product code is LHI – Set, I.V. Fluid Transfer, a Class II (moderate risk) device regulated under 21 CFR 880.5440.