# K213146: Safety butterfly type blood collection needle, Butterfly type blood collection needle, Pen type blood collection needle, Safety pen

- Pathway: 510(k) (Traditional)
- Applicant: Jiangsu Rongye Technology Co., Ltd.
- Decided: Oct 27, 2023 after 760 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Safety pen type blood Collection needle is intended to be used with vacuum blood collection tube for multiple collections of venous blood. The Safety butterfly type blood Collection needle is intended to be used with vacuum blood collection tube for multiple collections of venous blood. The pen type blood Collection needle is intended to be used with vacuum blood collection tube for multiple collections of venous blood. The butterfly type blood Collection needle is intended to be used with vacuum blood collection tube for multiple collections of venous blood.

Source page: https://510kreport.com/device/K213146
Methodology: https://510kreport.com/methodology