# K193569: Pivo (TM)

- Pathway: 510(k) (Special)
- Applicant: Velano Vascular
- Decided: Jan 21, 2020 after 29 days
- Product code: JKA (Tubes, Vials, Systems, Serum Separators, Blood Collection)
- Device class: 2
- Regulation: 21 CFR 862.1675
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K895367 (1989). 10 ancestors in all.
3 later devices descend from it; 1 cites 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)
- K190604: PIVO, Velano Vascular (2019) Summary page 4.

## Most influential descendants
- 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

## Recalls of this device
- Nov 10, 2021 · Class II · Z-0527-2022: Incomplete sealing of blood collection device unit packages may produce a breach in the sterile barrier enclosing the product. This could lead to microbial contamination of the device prior to use. Th

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

Source page: https://510kreport.com/device/K193569
Methodology: https://510kreport.com/methodology