# K212226: DR Safety Syringe, Sterile Hypodermic needle for Single use

- Pathway: 510(k) (Traditional)
- Applicant: Zhuhai DR Medical Instruments Co., Ltd.
- Decided: Sep 29, 2021 after 75 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: 7 generations back to K931367 (1993). 26 ancestors in all.
No later device cites it as a predicate yet.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092430: 1 ML Fixed Needle, 3 ML Luer Lock, 5 ML Luer Lock, 10 ML Luer Lock, 20 ML Luerl Lock Safety Syringes, Inviro Medical Devices, Inc. (2009) Summary page 4.
- K190002: Sterile Hypodermic Syringe for Single use, with/without needle, Sterile Insulin Syringe for Single use, with needle, Sterile Hypodermic needle for Single use, Shanghai Kohope Medical Devices Co., Ltd. (2019) Summary page 5.

## Indications for use
The DR Safety Syringe is used to inject fluids into or withdraw fluids from the body. In addition, the DR Safety Syringe is designed to aid in the prevention of needle stick injuries. The Sterile Hypodermic Needle for single use is intended for use with syringes and injection devices for general purpose fluid injection/aspiration.

Source page: https://510kreport.com/device/K212226
Methodology: https://510kreport.com/methodology