# K133351: Nexus Nis-6P Luer Activated Device

- Pathway: 510(k) (Traditional)
- Applicant: Nexus Medical, LLC
- Decided: May 22, 2014 after 203 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. The FDA summary names no predicate by number.

## Indications for use
The Nexus NIS®-6P is a pressure-rated, luer-activated, normally closed, bidirectional, neutral pressure 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 NIS®-6P may also be safely used with power injectors at lOmL/sec and pressures up to 325 psi. The Nexus NISOD-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/K133351
Methodology: https://510kreport.com/methodology