# K190604: PIVO

- Pathway: 510(k) (Special)
- Applicant: Velano Vascular
- Decided: May 13, 2019 after 66 days
- Product code: JKA (Tubes, Vials, Systems, Serum Separators, Blood Collection)
- Device class: 2
- Regulation: 21 CFR 862.1675
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K895367 (1989). 9 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163508: PIVO, Velano Vascular (2017) Summary page 4.

## Most influential descendants
- K193569: Pivo (TM) (2020), 3 descendants of its own
- K230865: PIVO™ Pro Needle-free Blood Collection Device (2023), 2 descendants of its own
- K244047: Navi™ Needle-free Blood Collection Device (VNC20500FG, VNC22500FG, VNC24500FG) (2025), 0 descendants of its own
- K241586: PIVO™ Pro Needle-free Blood Collection Device (2025), 0 descendants of its own
- K220258: 20G Open-System Ally Device Kit (AV100000), 22G Open-System Ally Device Kit (AV110000) (2022), 0 descendants of its own

## Indications for use
The PIVO™ device attaches to a peripheral IV catheter system for use as a direct blood draw device into a vacuum tube or a syringe.

Source page: https://510kreport.com/device/K190604
Methodology: https://510kreport.com/methodology