Nexus TKO-6, Luer-Activated Device
FDA 510(k) K113398 · Nexus Medical, LLC
510(k) numberK113398
Submission
- Device name
- Nexus TKO-6, Luer-Activated Device
- Applicant
- Nexus Medical, LLC
Lenexa, KS, US - Received
- November 17, 2011
- Decision date
- April 18, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- FPA – Set, Administration, Intravascular
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5440
- Specialty
- General Hospital
Other 510(k)s with product code FPA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K254123 | Ecomed Disposable Administration SetsFPA · Abbreviated | Ecomed Solutions, LLC | 09/11/2026SE |
| K261530 | iiSure Infusion SetFPA · Special | Deka Research and Development | 06/03/2026SE |
| K252543 | AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072…FPA · Traditional | Amsino International, Inc. | 05/04/2026SE |
| 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 |
|---|---|---|
| K142590 | All Safe Huber Safety Infusion SetFPA · Traditional | 01/16/2015SE |
| K133351 | Nexus NIS-6P Luer Activated DeviceFPA · Traditional | 05/22/2014SE |
| K130879 | Nexus IV Tubing Set with Luer-Accessbile One-Way Check Valve - IV PlusFPA · Traditional | 07/09/2013SE |
| K130416 | Nexus TKO-6P Luer Activated DeviceFPA · Traditional | 06/12/2013SE |
| K092382 | Nexus Pressure Rated Extension SetsFPA · Traditional | 04/26/2010SE |
| K092930 | Nexus Intravascular Tubing Sets-Pre-PiercedFPA · Special | 03/10/2010SE |
| K092527 | Nexus Injection Site, Model NIS-8FPA · Special | 02/04/2010SE |
| K081123 | Nexus I.V. Needless Access Cannula for Intravascular Administration SetsFPA · Traditional | 11/14/2008SE |
| K080976 | Nexus I.V. Fluid Transfer DeviceLHI · Traditional | 11/10/2008SE |
| K062551 | Nexus Irrigation Tubing SetLJH · Traditional | 12/15/2006SE |
Questions and answers
When was Nexus TKO-6, Luer-Activated Device cleared by the FDA?
Nexus TKO-6, Luer-Activated Device (K113398) received a 510(k) decision of Substantially Equivalent on April 18, 2012, 153 days after the submission was received.
What is the product code of K113398?
The FDA product code is FPA – Set, Administration, Intravascular, a Class II (moderate risk) device regulated under 21 CFR 880.5440.