Class Class II
Sofjec (K212635)
Description
Sofjec by Hwajin Medical Co., Ltd., an FDA 510(k) cleared general hospital device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK212635
Clearance Date2023-02-13
Clearance TypeTraditional
Product CodeFMF
Regulation Number880.5860
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K212635
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Sofjec (K212635) cites 2 predicate devices and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K190002 | Sterile Hypodermic Syringe for Single use, with/without nee... | Shanghai Kohope Medical Devices Co.... | 2019 |
| K173743 | Greenmedi Safety Filter Syringe | Sang-A Frontec Co., Ltd. | 2019 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K241856 | Sofjec (Single use Needle); Sofjec (Single use Syringe with... | Hlb Lifescience Co., Ltd. | 2024 |
Trace the full predicate network for K212635
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.