# K223323: Blood Collection Needle (with/without Needle Holder)

- Pathway: 510(k) (Traditional)
- Applicant: Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.
- Decided: Mar 24, 2023 after 144 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.
No later device cites it as a predicate yet.
0 of 9 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.

## Indications for use
The Blood Collection Needle (with/without needle holder) is intended to be used with a vacuum blood collection tube for the collection of venous blood.

Source page: https://510kreport.com/device/K223323
Methodology: https://510kreport.com/methodology