# K213811: Sterile Hypodermic Syringes for Single Use

- Pathway: 510(k) (Traditional)
- Applicant: Berpu Medical Technology Co., Ltd.
- Decided: May 12, 2022 after 156 days
- Product code: FMF (Syringe, Piston)
- 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). 23 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210227: Sterile syringe for single use with/without needle, Zhejiang Kangkang Medical-Devices Co., Ltd. (2021) Summary page 4.

## Most influential descendants
- K252279: Sterile Hypodermic Syringe for Single Use (20ml, 30ml, 50ml, 60ml) (2026), 0 descendants of its own

## Indications for use
The Sterile Hypodermic Syringes for Single Use are intended to be used for medical purposes on adult and pediatric population to inject fluids into or withdraw fluids from the body.

Source page: https://510kreport.com/device/K213811
Methodology: https://510kreport.com/methodology