# K220061: Safety Insulin Syringes

- Pathway: 510(k) (Traditional)
- Applicant: Berpu Medical Technology Co., Ltd.
- Decided: Aug 23, 2022 after 225 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 K000572 (2000). 35 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202570: Insulin Syringe, Insulin Syringe with Safety Retractable, Jiangsu Micsafe Medical Technology Co., Ltd. (2021) Summary page 4.

## Most influential descendants
- K230061: Insulin Syringe (2023), 0 descendants of its own

## Indications for use
The Safety Insulin Syringe is a sterile, single use and non-reusable syringe intended for injection of U-100 insulin into the body, while reducing the risk of sharps injuries and the potential for insulin syringe reuse.

Source page: https://510kreport.com/device/K220061
Methodology: https://510kreport.com/methodology