# K252899: Female Culture Device; Male Culture Device; Transfer Device; Access Device

- Pathway: 510(k) (Traditional)
- Applicant: Zhejiang Kindly Medical Device Co., Ltd.
- Decided: Jun 2, 2026 after 264 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: 5 generations back to K931367 (1993). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222478: BD Vacutainer® Luer-Lok™ Access Device, BD Vacutainer® Blood Transfer Device, Becton, Dickinson and Company (2023) Summary page 5.

## Indications for use
Female Culture Device is used for the collection of blood from a catheter hub or luer connector via vacuum-assisted collection device such as vacuum blood collection tube, sampling bottle. This device may also be used with a collection set with a male Luer to collect blood cultures. This device is to be used by properly trained healthcare professionals only in accordance with these instructions. Male Culture Device is used for the collection of blood from a catheter hub or luer connector via vacuum-assisted collection device such as vacuum blood collection tube, sampling bottle. This device may also be used with a collection set with a female Luer to collect blood cultures. This device is to be used by properly trained healthcare professionals only in accordance with these instructions. Transfer Device is used for the collection of blood from a catheter hub or luer connector via vacuum-assisted collection device such as vacuum blood collection tube, sampling bottle. This device may also be used with a collection set with a male Luer to collect blood cultures. This device is to be used by properly trained healthcare professionals only in accordance with these instructions. Access Device is used for the collection of blood from a catheter hub or luer connector via vacuum-assisted collection device such as vacuum blood collection tube, sampling bottle. This device may also be used with a collection set with a female Luer to collect blood cultures. This device is to be used by properly trained healthcare professionals only in accordance with these instructions.

Source page: https://510kreport.com/device/K252899
Methodology: https://510kreport.com/methodology