FDA 510(k) clearance · back to tracker

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

Hlb Lifescience Co., Ltd. cleared K253112 on 2026-05-21, decision: substantially equivalent

K-number

K253112

Sponsor

Hlb Lifescience Co., Ltd.

Device

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

Class

Class II

Decision

Substantially Equivalent

Decision date

2026-05-21

Product code

FMF

Advisory committee

General Hospital

Medical specialty

General Hospital

Regulation number

880.5860

Official FDA record

Open K253112on accessdata.fda.gov →

FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.

openFDA JSON

Raw record →

Machine-readable JSON. Useful for cross-referencing classification, product code, and advisory committee fields.

Use this as a predicate

Drop K253112 into Compass and start a substantial-equivalence draft.

Compass pulls the predicate's intended use, technological characteristics, and performance data, maps them against your device, and produces a draft SE table aligned to FDA's 510(k) program guidance.

Try the sandbox

Source

Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.