# K130416: Nexus Tko-6P Luer Activated Device

- Pathway: 510(k) (Traditional)
- Applicant: Nexus Medical, LLC
- Decided: Jun 12, 2013 after 113 days
- Product code: FPA (Set, Administration, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Nexus TKO®-6P is a pressure-rated, luer-activated, normally closed, bi-directional, neutral pressure anti-reflux device intended for use as an accessory to an IV catheter placed in the vein or artery for intravenous administration of blood, IV drugs and IV fluids to the patient including neonatal, pediatric and immunocompromised patients. The Nexus TKO®-6P may also be safely used with power injectors at 10mL/sec and pressures up to 325 psi. The Nexus TKO®-6P incorporates anti-reflux technology which prevents blood reflux resuiting from the following conditions: bag run-dry, connection and disconnection of luer lock devices, syringe plunger compression and patient vascular changes, such as coughing or sheezing. The Nexus TKO®-6P has a pre-slit septum which does not require the use of a stainless steel needle and passively aids in the reduction of needlestick injuries.

Source page: https://510kreport.com/device/K130416
Methodology: https://510kreport.com/methodology