Data / Medical devices / United States / Nexus Medical, LLC
Nexus Medical, LLC: FDA-registered device maker in Lenexa, KS, United States, 14 510(k) clearances
Nexus Medical, LLC is registered with the FDA (registration 3004194523) in Lenexa, KS, United States. It lists 7 device types. The FDA files 14 510(k) clearances under its listings, the newest dated July 9, 2013. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3004194523
- Address
- 11315 Strang Line Road, Lenexa, KS, United States, 66215
- Owner or operator
- NEXUS MEDICAL, LLC (9054517)
- Roles
- Contract manufacturer, Manufacturer, Specification developer
- First device listed
- May 24, 2007
- Registered through
- 2026
- Brand names listed
- IV Plus, IV plus, IVplus, Nexus Cannula, Nexus NIS-5, Nexus TKO, Nexus TKO-4S, Nexus TKO-6 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass | DTL | 2 | Manufacturer | accessdata.fda.gov |
| Arthroscope | HRX | 2 | Contract manufacturer | accessdata.fda.gov |
| Set, Administration, Intravascular | FPA | 2 | Contract manufacturer, Manufacturer, Specification developer | accessdata.fda.gov |
| Set, I.V. Fluid Transfer | LHI | 2 | Manufacturer | accessdata.fda.gov |
| System, Blood Collection, Vacuum-Assisted, Manual | KST | 1 | Manufacturer | accessdata.fda.gov |
| System, Irrigation, Urological | LJH | 2 | Contract manufacturer | accessdata.fda.gov |
| Tubes, Gastrointestinal (And Accessories) | KNT | 2 | Contract manufacturer, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 9, 2013 | K130879 | NEXUS IV TUBING SET WITH LUER-ACCESSBILE ONE-WAY CHECK VALVE - IV PLUS | FPA | Substantially Equivalent | Nexus Medical, LLC | accessdata.fda.gov |
| June 12, 2013 | K130416 | NEXUS TKO-6P LUER ACTIVATED DEVICE | FPA | Substantially Equivalent | Nexus Medical, LLC | accessdata.fda.gov |
| April 18, 2012 | K113398 | NEXUS TKO-6, LUER-ACTIVATED DEVICE | FPA | Substantially Equivalent | Nexus Medical, LLC | accessdata.fda.gov |
| April 26, 2010 | K092382 | NEXUS PRESSURE RATED EXTENSION SETS | FPA | Substantially Equivalent | Nexus Medical, LLC | accessdata.fda.gov |
| March 10, 2010 | K092930 | NEXUS INTRAVASCULAR TUBING SETS-PRE-PIERCED | FPA | Substantially Equivalent | Nexus Medical, LLC | accessdata.fda.gov |
| February 4, 2010 | K092527 | NEXUS INJECTION SITE, MODEL NIS-8 | FPA | Substantially Equivalent | Nexus Medical, LLC | accessdata.fda.gov |
| October 23, 2009 | K092418 | ENTRACARE GASTROSTOMY FEEDING TUBE | KNT | Substantially Equivalent | Entracare, LLC | accessdata.fda.gov |
| November 14, 2008 | K081123 | NEXUS I.V. NEEDLESS ACCESS CANNULA FOR INTRAVASCULAR ADMINISTRATION SETS | FPA | Substantially Equivalent | Nexus Medical, LLC | accessdata.fda.gov |
| November 10, 2008 | K080976 | NEXUS I.V. FLUID TRANSFER DEVICE | LHI | Substantially Equivalent | Nexus Medical, LLC | accessdata.fda.gov |
| January 12, 2006 | K053049 | ALARIS SAFETY MALE LUER | FPA | Substantially Equivalent | Cardinal Health, Alaris Products | accessdata.fda.gov |
| December 8, 2005 | K053129 | NEXUSTKO NEEDLELESS ACCESS DEVICE, MODEL NIS-5 | FPA | Substantially Equivalent | Nexus Medical, LLC | accessdata.fda.gov |
| November 26, 2004 | K041861 | NEXUS INTRAVENOUS TUBING SETS (NIVTS) | FPA | Substantially Equivalent | Nexus Medical, LLC | accessdata.fda.gov |
| August 24, 2004 | K041845 | NEXUS PAV LUER LOCK DEVICE, MODEL NIS-4 | FPA | Substantially Equivalent | Nexus Medical, LLC | accessdata.fda.gov |
| April 26, 1989 | K890176 | EXTENSION SETS WITH AND WITHOUT FILTERS | FPA | Substantially Equivalent | Medical Support Systems | accessdata.fda.gov |
Compare with other makers
- All makers of Set, Administration, Intravascular
- All makers of Arthroscope
- All makers of System, Irrigation, Urological
- All makers of System, Blood Collection, Vacuum-Assisted, Manual
- All makers of Set, I.V. Fluid Transfer
- All makers of Tubes, Gastrointestinal (And Accessories)
Updated July 9, 2013. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.