# K190002: Sterile Hypodermic Syringe for Single use, with/without needle, Sterile Insulin Syringe for Single use, with needle, Sterile Hypodermic needle for Single use

- Pathway: 510(k) (Traditional)
- Applicant: Shanghai Kohope Medical Devices Co., Ltd.
- Decided: Sep 12, 2019 after 253 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: 6 generations back to K931367 (1993). 22 ancestors in all.
13 later devices descend from it; 8 cite it directly.
0 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112057: KDL Syringes and Needle, Shanghai Kindly Enterprise Dev. Group Co., (2011) Summary page 7.

## Most influential descendants
- K212635: Sofjec (2023), 2 descendants of its own
- K201284: Sterile Hypodermic Syringe for Single Use, with/without needle, luer/luer-lock, Sterile Insulin Syringe for Single Use, with needle, Sterile Hypodermic needle for Single use (2020), 2 descendants of its own
- K241856: Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); Sofjec (Membrane Filter Syringe) (2024), 1 descendant of its own
- K201044: CHIRANA Insulin Syringes (2022), 1 descendant of its own
- K253112: Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); Sofjec (Membrane Filter Syringe) (2026), 0 descendants of its own

## Indications for use
The sterile Hypodermic Syringe for Single use, with/without needle is intended to be used for medical purposes to inject fluid into or withdraw fluid from body. The sterile Insulin Syringe for Single use with needle, with the calibration unit of insulin for U-100, is a device intended for medical purposes for the manual aspiration of insulin, and for the injection of insulin into parts of insulin into parts of the body below the surface skin. The sterile Insulin Syringe for Single use with needle, with the calibration unit of insulin for U-40, is a device intended for medical purposes for the manual aspiration of insulin, and for the injection of insulin into parts of insulin into parts of the body below the surface skin. 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/K190002
Methodology: https://510kreport.com/methodology