# K200027: Blood Collection Needle with/without Holder, Safety Blood Collection Needle with/without Holder, Luer Access Device-holder with Preattached Multiple Sample Adapter

- Pathway: 510(k) (Traditional)
- Applicant: Jiangsu Caina Medical Co.,Ltd
- Decided: Sep 9, 2020 after 247 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 K931367 (1993). 7 ancestors in all.
6 later devices descend from it; 5 cite it directly.
0 of 14 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.
- K991088: Vacutainer Brand Multiple Sample Luer Adapter, Blood Collection Sets and Safety-Lok Blood Collection, Safety Blood Colle, Becton Dickinson Vacutainer Systems (1999) Summary page 6.

## Most influential descendants
- K222478: BD Vacutainer® Luer-Lok™ Access Device, BD Vacutainer® Blood Transfer Device (2023), 1 descendant of its own
- K252899: Female Culture Device; Male Culture Device; Transfer Device; Access Device (2026), 0 descendants of its own
- K233979: VACUETTE® QUICKSHIELD Complete (Plus) (2024), 0 descendants of its own
- K223323: Blood Collection Needle (with/without Needle Holder) (2023), 0 descendants of its own
- K213690: Eclipse Blood Collection Set (2022), 0 descendants of its own

## Indications for use
The Blood Collection Needle with/without holder is intended to be used with vacuum blood collection tube for the collection of venous blood. The Safety Blood Collection Needle with/without holder is intended to be used with vacuum blood collection tube for the collection of venous blood. The safety shield is intended to aid in the protection against accidental needle stick injury. The Luer access device- holder with preattached multiple sample adapter is a sterile, non-invasive device used to connect devices with male or female luer connectors to blood collection tubes for the collection of blood.

Source page: https://510kreport.com/device/K200027
Methodology: https://510kreport.com/methodology