# K230865: PIVO™ Pro Needle-free Blood Collection Device

- Pathway: 510(k) (Traditional)
- Applicant: Becton Dickinson Infusion Therapy Systems, Inc.
- Decided: Sep 28, 2023 after 183 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: 8 generations back to K895367 (1989). 11 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193569: Pivo (TM), Velano Vascular (2020) Summary page 5.

## Most influential descendants
- 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

## Indications for use
The PIVO™ Pro Needle-free Blood Collection Device attaches to a peripheral IV catheter system for use to obtain venous blood specimens into a vacuum tube or syringe from adult and pediatric patients, including those with difficult intravenous access who may have small, fragile, and/or non-palpable veins.

Source page: https://510kreport.com/device/K230865
Methodology: https://510kreport.com/methodology