# K242320: BD Vacutainer® One Use Holder

- Pathway: 510(k) (Traditional)
- Applicant: Becton, Dickinson and Company
- Decided: Nov 1, 2024 after 88 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 K895367 (1989). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122687: Blood Culture Holder, Greiner Bio-One North America, Inc. (2013) Summary page 5.

## Indications for use
The BD Vacutainer@ One Use Holder is a single-use, non-sterile device used by healthcare professionals to attach and hold a BD Vacutainer@ brand venous access device such as a blood collection needle, a blood collection set, or a luer adapter during venipuncture connected to a BD Vacutainer@ blood collection tube(s). This device may also be used with a BD Vacutainer@ blood collection set with a luer adapter to obtain blood samples into a BD BACTECTm blood culture bottle.

Source page: https://510kreport.com/device/K242320
Methodology: https://510kreport.com/methodology