# 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

- Pathway: 510(k) (Traditional)
- Applicant: Jiangsu Micsafe Medical Technology Co., Ltd.
- Decided: Nov 4, 2021 after 129 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: 3 generations back to K972404 (1997). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172763: Blood Collecting Needle, Safety Blood Collecting Needle, Blood Collecting Needle with Holder, Safety Blood Collecting Needle with Holder, Blood Collecting Set, Safety Blood Collecting Set, Blood Collecting Set with Holder, Safety Blood Collecting Set with Holder, Zhejiang Kindly Medical Devices Co., Ltd. (2018) Summary page 6.

## Most influential descendants
- K220900: Safety Blood Collection Needles with/without Needle Holder (2022), 0 descendants of its own

## Indications for use
(1) Blood Collection Needle for Single Use The Blood Collection Needle for Single Use is intended to be used with vacuum blood collection tube for multiple collections of venous blood. (2) Safety Blood Collection Needle for Single Use The Safety Blood Collection Needle for Single Use is intended to be used with vacuum blood collection tube for multiple collections of venous blood. The safety shield is intended to aid in the protection against accidental needle stick injury. (3) Blood Collection Needle with Holder for Single Use The Blood Collection Needle with Holder for Single Use is intended to be used with vacuum blood collection tube for multiple collections of venous blood. (4) Safety Blood Collection Needle with Holder for Single Use The Safety Blood Collection Needle with Holder for Single Use is intended to be used with vacuum blood collection tube for multiple collections of venous blood. The safety shield is intended to aid in the protection against accidental needle stick injury. (5) Blood Collection Set for Single Use The Blood Collection Set for Single Use is intended to be used with vacuum blood collection tube for multiple collections of venous blood. (6) Safety Blood Collection Set for Single Use The Safety Blood Collection Set for Single Use is intended to be used with vacuum blood collection tube for multiple collections of venous blood. The safety shield is intended to aid in the protection against accidental needle stick injury. (7) Blood Collection Set with Holder for Single Use The Blood Collection Set with Holder for Single Use is intended to be used with vacuum blood collection tube for multiple collections of venous blood. (8) Safety Blood Collection Set with Holder for Single Use The Safety Blood Collection Set with Holder for Single Use is intended to be used with vacuum blood collection tube for multiple collections of venous blood. The safety shield is intended to aid in the protection against accidental needle stick injury.

Source page: https://510kreport.com/device/K212019
Methodology: https://510kreport.com/methodology