# K182897: Velano Vascular Q2 Extension Set

- Pathway: 510(k) (Traditional)
- Applicant: Velano Vascular
- Decided: Mar 26, 2019 after 161 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: 8 generations back to K942988 (1995). 18 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162804: Q2 Low Pressure Power Injection Extension Set, Quest Medical, Inc. (2017) Summary page 4.

## Most influential descendants
- K200439: Velano ExT Extension Set (2021), 2 descendants of its own
- K251257: nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte Needle Free Connector (NFC) [6426731]; nSyte Needle Free Connector (NFC) [6426727] (2025), 0 descendants of its own
- K221518: NP Medical nCompass Extension Set with Stabilizing Base (2022), 0 descendants of its own

## Indications for use
Pressure Rated: The Q2® Extension Set with needleless connector is for single use only. The extension set may be used for direct injection, intermittent infusion, continuous infusion or aspiration. This set may be used with power injector procedures to a maximum pressure of 325 psi at a flow rate of 10ml per second. Non Pressure Rated: The Q2® Extension Set with needleless connector is for single use only. The extension set may be used for direct injection, intermittent infusion, continuous infusion or aspiration.

Source page: https://510kreport.com/device/K182897
Methodology: https://510kreport.com/methodology