Closed Male Luer
FDA 510(k) K171101 · Yukon Medical
510(k) numberK171101
Submission
- Device name
- Closed Male Luer
- Applicant
- Yukon Medical
Durham, NC, US - Received
- April 13, 2017
- Decision date
- June 2, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
Device classification
- Product code
- FPA – Set, Administration, Intravascular
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5440
- Specialty
- General Hospital
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| K254123 | Ecomed Disposable Administration SetsFPA · Abbreviated | Ecomed Solutions, LLC | 09/11/2026SE |
| K261530 | iiSure Infusion SetFPA · Special | Deka Research and Development | 06/03/2026SE |
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| K251375 | PuraCath Firefly Needleless Connector IT (9005)FPA · Traditional | Puracath Medical, Inc. | 02/12/2026SE |
| K251257 | nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte Needle Free…FPA · Traditional | Np Medical | 12/04/2025SE |
| K250325 | BD Alaris Pump Infusion SetFPA · Traditional | Carefusion (Bd) | 10/30/2025SE |
| K251814 | EZ IV Administration SetFPA · Traditional | Epic Medical Pte. , Ltd. | 08/29/2025SE |
| K251854 | SteadiSet infusion setFPA · Abbreviated | Tandem Diabetes Care | 08/06/2025SE |
| K243841 | Sparta Infusion Set for InsulinFPA · Traditional | Deka Research and Development | 08/01/2025SE |
| K243392 | Infusomat® Space Volumetric Infusion Pump Administration SetsFPA · Traditional | B.Braun Medical, Inc. | 07/24/2025SE |
More from B.Braun Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K240761 | Arisure® Closed Male Luer with Spike Adapter (YM060)LHI · Traditional | 03/21/2025SE |
| K243486 | SmartSiteTM Vented Vial Access DeviceLHI · Traditional | 12/06/2024SE |
| K201422 | Arisure Closed System Drug Transfer Device (CSTD)ONB · Traditional | 03/02/2021SE |
| K172884 | Arisure Closed Vial AdapterLHI · Traditional | 10/03/2017SE |
| K172631 | Arisure Dry SpikeLHI · Traditional | 09/29/2017SE |
| K151963 | SmartSite Vented Vial Access DeviceLHI · Traditional | 07/31/2015SE |
| K132863 | Smartsite VialshieldLHI · Traditional | 10/04/2013SE |
| K122265 | Vialok Single Vial Access Device VentedLHI · Traditional | 08/14/2012SE |
| K121182 | Vialok Non-VentedLHI · Traditional | 05/03/2012SE |
| K120799 | Arisure Neutral ValveFPA · Traditional | 03/30/2012SE |
Questions and answers
When was Closed Male Luer cleared by the FDA?
Closed Male Luer (K171101) received a 510(k) decision of Substantially Equivalent on June 2, 2017, 50 days after the submission was received.
What is the product code of K171101?
The FDA product code is FPA – Set, Administration, Intravascular, a Class II (moderate risk) device regulated under 21 CFR 880.5440.