# K191644: TK Safety Needle

- Pathway: 510(k) (Traditional)
- Applicant: Anhui Tiankang Medical Technology Co., Ltd.
- Decided: Aug 6, 2020 after 414 days
- Product code: FMI (Needle, Hypodermic, Single Lumen)
- Device class: 2
- Regulation: 21 CFR 880.5570
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K904198 (1990). 23 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142765: TM Safety Needle, Thinkmed Medical Technology Co., Ltd. (2015) Summary page 4.

## Most influential descendants
- K231723: Sterile Safety Hypodermic Needles for Single Use (2023), 0 descendants of its own
- K220603: Disposable Medical Safety Hypodermic Needle (2022), 0 descendants of its own
- K213535: Sterile Safety Hypodermic Needles for Single Use (2022), 0 descendants of its own

## Indications for use
TK Safety Needle device is intended for use in the aspiration and injection of fluids for medical purposes. The TK Safety Needle is compatible for use with standard luer slip and luer lock syringes. Additionally, after withdrawal of the needle from the body the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needle-stick.

Source page: https://510kreport.com/device/K191644
Methodology: https://510kreport.com/methodology