# 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

- Pathway: 510(k) (Traditional)
- Applicant: Zhejiang Kindly Medical Devices Co., Ltd.
- Decided: Jun 4, 2018 after 264 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: 2 generations back to K972404 (1997). 3 ancestors in all.
13 later devices descend from it; 4 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982541: Vacutainer Brand Eclipse Blood Collection Needle, Models# 368607 & 368608, Becton Dickinson Vacutainer Systems (1998) Summary page 10.
- K965202: Vacutainer Brand Safety-Lok Blood Collection Set, Bd Becton Dickinson Vacutainer Systems Preanalytic (1997) Summary page 10.

## Most influential descendants
- K200027: Blood Collection Needle with/without Holder, Safety Blood Collection Needle with/without Holder, Luer Access Device-holder with Preattached Multiple Sample Adapter (2020), 6 descendants of its own
- K230080: Blood Collection Set, Blood Collection Set with Holder, Safety Blood Collection Set, Safety Blood Collection Set with Holder, Blood (2023), 1 descendant of its own
- K222478: BD Vacutainer® Luer-Lok™ Access Device, BD Vacutainer® Blood Transfer Device (2023), 1 descendant of its own
- 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 (2021), 1 descendant of its own
- K182146: Sol-M Blood Collection Needles, Sol-Care Safety Blood Collection Needles, Sol-Care Safety Blood Collection Needle with Holders, Sol-M Blood Collection Set (2018), 1 descendant of its own

## Indications for use
The Blood Collecting Needle is intended to be used with vacuum blood collection tube for multiple collections of venous blood. The Safety Blood Collecting 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 Blood Collecting Needle with Holder is intended to be used with vacuum blood collection tube for multiple collections of venous blood. The Safety Blood Collecting 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 Blood Collecting Set is intended to be used with vacuum blood collection tube for multiple collections of venous blood. The Safety Blood Collecting 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 Blood Collecting Set with Holder is intended to be used with vacuum blood collection tube for multiple collections of venous blood. The Safety Blood Collecting 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.

Source page: https://510kreport.com/device/K172763
Methodology: https://510kreport.com/methodology