# K243649: BD Vacutainer® Multiple Sample Luer Adapter

- Pathway: 510(k) (Traditional)
- Applicant: Becton, Dickinson and Company
- Decided: Mar 21, 2025 after 115 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 K931367 (1993). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991088: Vacutainer Brand Multiple Sample Luer Adapter, Blood Collection Sets and Safety-Lok Blood Collection, Safety Blood Colle, Becton Dickinson Vacutainer Systems (1999) Summary page 5.

## Indications for use
The BD Vacutainer® Multiple Sample Luer Adapter is a sterile, single-use, non-invasive medical device intended to be connected with BD Vacutainer® brand needle holders, to enable blood collection from venous access devices, such as needles and blood collection sets or catheters with female luer connectors into blood collection tubes or blood culture bottles for the purpose of in vitro diagnostic testing. These devices are intended to be used by healthcare professionals.

Source page: https://510kreport.com/device/K243649
Methodology: https://510kreport.com/methodology