# 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

- Pathway: 510(k) (Traditional)
- Applicant: Berpu Medical Technology Co., Ltd.
- Decided: Aug 9, 2018 after 175 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). 31 ancestors in all.
12 later devices descend from it; 8 cite it directly.
0 of 44 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072739: Jierui Syringes and Needles, Shandong Weigao Group Medical Polymer Co., Ltd. (2008) Summary page 6.
- K113422: Terumo Surguard 3 Safety Needle Terumo Surguard 3 Hypodermic Syringe with Safety Needle, Terumo (Philippines) Corporation (2012) Summary page 6.

## Most influential descendants
- K211214: Sterile Hypodermic Needles for Single Use (2021), 4 descendants of its own
- K223334: Sterile Hypodermic Needles for Single Use (2022), 1 descendant of its own
- K221079: Sterile Hypodermic Syringes for Single Use (2022), 1 descendant of its own
- K252631: Profoject™ Disposable Needle (2025), 0 descendants of its own
- K242099: Sol-M™ Slip Tip Syringe without Needle, Sol-M™ Eccentric Tip Syringe without Needle (2024), 0 descendants of its own

## Indications for use
The Self-destruction Safety Syringes for Single Use are intended to be used for medical purposes to inject fluid into or withdraw fluid from body. 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. The Sterile Hypodermic Syringes for Single Use are intended to be used for medical purpose to inject fluid into or withdraw fluid from body. The Sterile Hypodermic Needles for Single Use are intended to be used with a luer slip or luer slip syringe and injection devices for general purpose fluid injection/aspiration. The Sterile Safety Hypodermic Needles for Single Use are intended to be used with a luer slip or luer slip 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/K180417
Methodology: https://510kreport.com/methodology