# K201237: Velano Vascular Blood Collection Adapter

- Pathway: 510(k) (Traditional)
- Applicant: Velano Vascular
- Decided: Oct 3, 2022 after 879 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 K970259 (1997). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192247: Steripath Gen2 Blood Collection System, Magnolia Medical Technologies, Inc. (2020) Summary page 4.

## Indications for use
The Velano Vascular Blood Collection Adapter is indicated for use as a blood collection system that manually diverts the initial specimen prior to collection of a subsequent test sample to reduce the frequency of blood culture contamination when contaminants are present in the initial blood sample compared to blood cultures drawn with standard procedure without manual diversion.

Source page: https://510kreport.com/device/K201237
Methodology: https://510kreport.com/methodology