# K041358: Venoject Luer Adapter

- Pathway: 510(k) (Traditional)
- Applicant: Terumo Europe N.V.
- Decided: May 28, 2004 after 7 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: 2 generations back to K931367 (1993). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983490: Terumo Venoject,Luer Adapter, Terumo Corp. (1998) Summary page 1.

## Indications for use
The Terumo Venoject Luer Adapter is a sterile, non-invasive device that permits blood specimen collection from hypodermic needles, blood vessel catheters, or blood collection systems/devices with luer fittings. When blood samples are to be obtained with a single venipuncture, the luer adapter is a conduit between the collection needle and the collection container.

Source page: https://510kreport.com/device/K041358
Methodology: https://510kreport.com/methodology