# K142946: TIVA

- Pathway: 510(k) (Traditional)
- Applicant: Velano Vascular, Inc.
- Decided: Jan 8, 2015 after 90 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: 3 generations back to K895367 (1989). 6 ancestors in all.
8 later devices descend from it; 1 cites 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)
- K081229: Saf-T Closed Blood Collection System with Saf-Holder Device, with 21G, 23G, 25G Saf-T Wing, Smiths Medical Asd, Inc. (2008) Summary page 4.

## Most influential descendants
- K152924: TIVA¿ (2016), 7 descendants of its own
- K163508: PIVO (2017), 6 descendants of its own
- K190604: PIVO (2019), 5 descendants of its own
- K193569: Pivo (TM) (2020), 3 descendants of its own
- K230865: PIVO™ Pro Needle-free Blood Collection Device (2023), 2 descendants of its own

## Indications for use
The TIVA™ device is attached to a peripheral IV catheter at the time of IV catheter placement for use as a direct blood draw device into a vacuum tube or a syringe.

Source page: https://510kreport.com/device/K142946
Methodology: https://510kreport.com/methodology