# K212635: Sofjec

- Pathway: 510(k) (Traditional)
- Applicant: Hwajin Medical Co., Ltd.
- Decided: Feb 13, 2023 after 543 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). 27 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190002: Sterile Hypodermic Syringe for Single use, with/without needle, Sterile Insulin Syringe for Single use, with needle, Sterile Hypodermic needle for Single use, Shanghai Kohope Medical Devices Co., Ltd. (2019) Summary page 5.
- K173743: Greenmedi Safety Filter Syringe, Sang-A Frontec Co., Ltd. (2019) Summary page 5.

## Most influential descendants
- K241856: Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); Sofjec (Membrane Filter Syringe) (2024), 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
Single use Needle Single use Needle is intended for use with syringes and injection devices for general purpose fluid injection/aspiration. Single use Syringe with Needle Single use Syringe with Needle is intended to be used for medical purposes to inject fluid into or withdraw fluid from body. Membrane Filter Syringe Membrane Filter Syringe is intended to be used for medical purposes to inject fluid into or withdraw fluid from body. The filter operates when injecting the drug into the human body to remove foreign substances from the drug solutions.

Source page: https://510kreport.com/device/K212635
Methodology: https://510kreport.com/methodology