# K220603: Disposable Medical Safety Hypodermic Needle

- Pathway: 510(k) (Traditional)
- Applicant: Hantech Medical Device Co., Ltd.
- Decided: Aug 23, 2022 after 174 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: 8 generations back to K904198 (1990). 24 ancestors in all.
No later device cites it as a predicate yet.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191644: TK Safety Needle, Anhui Tiankang Medical Technology Co., Ltd. (2020) Summary page 4.

## Indications for use
The Disposable Medical Safety Hypodermic Needle is intended for use in the aspiration and injection of fluids for medical purposes. The Disposable Medical Safety Hypodermic 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/K220603
Methodology: https://510kreport.com/methodology