# K220900: Safety Blood Collection Needles with/without Needle Holder

- Pathway: 510(k) (Traditional)
- Applicant: Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.
- Decided: Aug 10, 2022 after 135 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 K972404 (1997). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212019: Blood Collection Needle for Single Use & Blood Collection Needle with Holder for Single Use, Safety Blood Collection Needle for Single Use, Safety Blood Collection Needle with Holder for Single Use, Blood Collection Set for Single Use & Safety Blood Collection Set with Holder for Single Use, Safety Blood Collection Set for Single Use & Blood Collection Set with Holder for Single, Jiangsu Micsafe Medical Technology Co., Ltd. (2021) Summary page 4.

## Indications for use
Safety blood collection needles with/without needle holder are intended to be used with vacuum blood collection tubes for multiple collections of venous blood. The safety shield is intended to aid in the protection against, accidental needle stick injuries.

Source page: https://510kreport.com/device/K220900
Methodology: https://510kreport.com/methodology