# K053519: Safety Syringe

- Pathway: 510(k) (Traditional)
- Applicant: Wuxi Yushou Medical Applicances Co., Ltd.
- Decided: Aug 11, 2006 after 235 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: 1 generation back to K011103 (2001). 1 ancestor in all.
79 later devices descend from it; 1 cites it directly.
0 of 81 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011103: BD Spring Based Syringe, Bd (2001). Our reading of the summary gave K001103, FDA’s number for Wireless Ambulatory Eeg, Model EX-Amb-Wireless (Proposed) (Excel Tech., Ltd.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “BD Spring Based Syringe”.

## Most influential descendants
- K072739: Jierui Syringes and Needles (2008), 78 descendants of its own
- K110421: Disposable Insulin Syringe (2011), 36 descendants of its own
- K112057: KDL Syringes and Needle (2011), 31 descendants of its own
- K190002: Sterile Hypodermic Syringe for Single use, with/without needle, Sterile Insulin Syringe for Single use, with needle, Sterile Hypodermic needle for Single use (2019), 13 descendants of its own
- K180417: Self-destruction Safety Syringes for Single Use; Sterile Hypodermic Syringes for Single Use; Sterile Hypodermic Needles for Single Use; Sterile Safety Hypodermic Needles for Single Use (2018), 12 descendants of its own

## Indications for use
The device's primary intended use is general purpose injection of fluids into, or withdrawal of fluids from the body, below the surface of the skin except for phlebotomy. Its secondary intended use is to retract inside the safety barrel, contain the contaminated needle and aid in the prevention of accidental needle stick injuries.

Source page: https://510kreport.com/device/K053519
Methodology: https://510kreport.com/methodology