# K221518: NP Medical nCompass Extension Set with Stabilizing Base

- Pathway: 510(k) (Traditional)
- Applicant: Np Medical
- Decided: Nov 3, 2022 after 162 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 4.

## Indications for use
The NP Medical Extension Set with stabilizing base is a sterile single patient use device. The NP Medical Extension Set is intended for direct injection, intermittent infusion, continuous infusion or aspiration for all patients for which IV therapy is prescribed. The NP Medical Extension Set incorporates a normally closed bidirectional pressure-activated valve that prevents low pressure retrograde flow and is intended for power injector procedures to a maximum pressure of 325 psi at a flow rate of 10ml per second.

Source page: https://510kreport.com/device/K221518
Methodology: https://510kreport.com/methodology