# K241856: Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); Sofjec (Membrane Filter Syringe)

- Pathway: 510(k) (Special)
- Applicant: Hlb Lifescience Co., Ltd.
- Decided: Dec 23, 2024 after 179 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: 8 generations back to K931367 (1993). 28 ancestors in all.
1 later device descends 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)
- K212635: Sofjec, Hwajin Medical Co., Ltd. (2023) Summary page 5.

## Most influential descendants
- 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(108 model codes including Sofjec-16-13) Single use Needle is intended for use with syringes and injection devices for general purpose fluid injection/aspiration. Single use Syringe with or without Needle (2186 model codes including HJ-1-16G-13) Single use Syringe with or without Needle is intended to be used for medical purposes to inject fluid into or withdraw fluid from body. Membrane Filter Syringe (16 model codes including HJM-18-1) 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/K241856
Methodology: https://510kreport.com/methodology