# K053129: Nexustko Needleless Access Device, Model Nis-5

- Pathway: 510(k) (Special)
- Applicant: Nexus Medical, LLC
- Decided: Dec 8, 2005 after 30 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 NIS-5 Is a needle-less device intended as an intravascular administration set accessory for the delivery of drugs and fluids, The NIS-5 device may aid in the prevention of needle stick injuries.

Source page: https://510kreport.com/device/K053129
Methodology: https://510kreport.com/methodology