# K983490: Terumo Venoject,Luer Adapter

- Pathway: 510(k) (Traditional)
- Applicant: Terumo Corp.
- Decided: Nov 30, 1998 after 56 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: 1 generation back to K931367 (1993). 1 ancestor in all.
21 later devices descend from it; 3 cite it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K931367: Vacutainer Brand Luer Adapter, Bd Becton Dickinson Vacutainer Systems Preanalytic (1993) Summary page 1.

## Most influential descendants
- K991088: Vacutainer Brand Multiple Sample Luer Adapter, Blood Collection Sets and Safety-Lok Blood Collection, Safety Blood Colle (1999), 14 descendants of its own
- K200027: Blood Collection Needle with/without Holder, Safety Blood Collection Needle with/without Holder, Luer Access Device-holder with Preattached Multiple Sample Adapter (2020), 6 descendants of its own
- K013164: Surshield Safety Winged Blood Collection Set (2001), 4 descendants of its own
- K031279: Surshield Safety Winged Blood Collection Set (2003), 3 descendants of its own
- K222478: BD Vacutainer® Luer-Lok™ Access Device, BD Vacutainer® Blood Transfer Device (2023), 1 descendant of its own

## 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/K983490
Methodology: https://510kreport.com/methodology