# K253112: 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: May 21, 2026 after 239 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: 9 generations back to K931367 (1993). 29 ancestors in all.
No later device cites it as a predicate yet.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K241856: Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); Sofjec (Membrane Filter Syringe), Hlb Lifescience Co., Ltd. (2024) Summary page 6.

## Indications for use
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 is intended to be used for medical purposes to inject fluid into or withdraw fluid from body. 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/K253112
Methodology: https://510kreport.com/methodology