# K222478: BD Vacutainer® Luer-Lok™ Access Device, BD Vacutainer® Blood Transfer Device

- Pathway: 510(k) (Traditional)
- Applicant: Becton, Dickinson and Company
- Decided: Mar 10, 2023 after 206 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: 4 generations back to K931367 (1993). 8 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200027: Blood Collection Needle with/without Holder, Safety Blood Collection Needle with/without Holder, Luer Access Device-holder with Preattached Multiple Sample Adapter, Jiangsu Caina Medical Co.,Ltd (2020) Summary page 4.

## Most influential descendants
- K252899: Female Culture Device; Male Culture Device; Transfer Device; Access Device (2026), 0 descendants of its own

## Indications for use
BD Vacutainer® Luer-Lok™ Access Device: The BD Vacutainer® Luer-Lok™ Access Device is a sterile, single-use, noninvasive device intended to be used by healthcare professionals for safe, closed-system venous blood collection from a female Luer of a catheter port or blood collection set, directly into an evacuated blood collection tube(s) for in vitro diagnostic testing. This device may also be used with a blood collection set with a female Luer to collect blood cultures. BD Vacutainer® Blood Transfer Device: The BD Vacutainer® Blood Transfer Device is a sterile, single use, noninvasive medical device intended to be used by healthcare professionals for the safe, closed-system, needleless transfer of venous blood from a BD Luer-Lok™ tip syringe into evacuated blood collection tube(s) or blood culture bottle(s) for in vitro diagnostic testing.

Source page: https://510kreport.com/device/K222478
Methodology: https://510kreport.com/methodology