# K251257: nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte Needle Free Connector (NFC) [6426731]; nSyte Needle Free Connector (NFC) [6426727]

- Pathway: 510(k) (Traditional)
- Applicant: Np Medical
- Decided: Dec 4, 2025 after 225 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
Longest line of descent: 10 generations back to K942988 (1995). 20 ancestors in all.
No later device cites it as a predicate yet.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200439: Velano ExT Extension Set, Velano Vascular (2021) Summary page 5.

## Indications for use
The nSet+ Stabilization Set is for single use only. The nSet+ Extension Set may be used for direct injection, intermittent infusion, continuous infusion or aspiration. The nSet+ Extension Set may be used with power injector procedures to a maximum pressure of 325 psi at a flow rate of 10 ml per second. The nSet+ Stabilization Set with nSyte needle free connector is for single use only. The nSet+ Extension Set may be used for direct injection, intermittent infusion, continuous infusion or aspiration. The nSet+ Stabilization Set may be used with power injector procedures to a maximum pressure of 325 psi at a flow rate of 10 ml per second. The nSyte needle free connector is for single use only. The nSyte needle free connector may be used for direct injection, intermittent infusion, continuous infusion or aspiration. The nSyte needle free connector may be used with power injector procedures to a maximum pressure of 325 psi at a flow rate of 10 ml per second.

Source page: https://510kreport.com/device/K251257
Methodology: https://510kreport.com/methodology