# K190183: Hypodermic Safety Needle, Hypodermic Safety Needle with Syringe

- Pathway: 510(k) (Traditional)
- Applicant: Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.
- Decided: Oct 4, 2019 after 245 days
- Product code: MEG (Syringe, Antistick)
- Device class: 2
- Regulation: 21 CFR 880.5860
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K904198 (1990). 11 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113422: Terumo Surguard 3 Safety Needle Terumo Surguard 3 Hypodermic Syringe with Safety Needle, Terumo (Philippines) Corporation (2012) Summary page 4.
- K051865: Terumo Surguard 2 Safety Needle or Similar, Terumo Medical Corp. (2005) Summary page 4.

## Most influential descendants
- K211555: Hypodermic Safety Needle; Hypodermic Safety Needle with Syringe (2021), 0 descendants of its own

## Indications for use
The Hypodermic Safety Needle with Syringe is intended for use in the aspiration and injection of fluids for medical purpose. 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 sticks. The Hypodermic Safety Needle is intended to be used with a luer lock syringe for aspiration and injection of fluids for medical purpose. 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 needlestick.

Source page: https://510kreport.com/device/K190183
Methodology: https://510kreport.com/methodology