# K230080: Blood Collection Set, Blood Collection Set with Holder, Safety Blood Collection Set, Safety Blood Collection Set with Holder, Blood

- Pathway: 510(k) (Traditional)
- Applicant: Yangzhou Medline Industry, Co., Ltd.
- Decided: Jul 7, 2023 after 177 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
- K250961: Blood collection tube holders (2025), 0 descendants of its own

## Indications for use
The Blood Collection Set is intended to be used with vacuum blood collection tube for multiple collections of venous blood. The Blood Collection Set with Holder is intended to be used with vacuum blood collection tube for multiple collections of venous blood. The Safety Blood Collection Set 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. The Safety Blood Collection Set with Holder 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. The Blood Collection Needle is intended to be used with vacuum blood collection tube for multiple collections of venous blood. The Blood Collection Needle with Holder is intended to be used with vacuum blood collection tube for multiple collections of venous blood. The Safety Blood Collection Needle 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. The Safety Blood Collection Needle with Holder 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. The Luer adapter with Holder is intended to be used with vein puncture needle and vacuum blood collection tube for multiple collections of venous blood.

Source page: https://510kreport.com/device/K230080
Methodology: https://510kreport.com/methodology