Sofjec (3 models)— 510(k) K253112

Name: FDA 510(k) clearance K253112
Creator: U.S. Food and Drug Administration
Published: 2026-05-21

Substantially Equivalent

Hlb Lifescience Co., Ltd.

FDA 510(k) clearance K253112 for Sofjec (3 models), Substantially Equivalent on 2026-05-21. Applicant: Hlb Lifescience Co., Ltd.. Device class: 2.

Clearance details

Device name as filed: Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); Sofjec (Membrane Filter Syringe)
Applicant: Hlb Lifescience Co., Ltd.
Product code: Code FMF
Device class: Class 2
Regulation: 21 CFR 880.5860
Advisory panel: General Hospital
Date received: 2025-09-24
Decision date: 2026-05-21
Decision: Substantially Equivalent
Clearance type: Special
Location: Anseong-Si, KR

Download summary PDF View on FDA.gov ↗

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K253747 — Disposable Pen Injector (KXYC-03C02, KXYC-03A03)2026-08-14
K260208 — Ultra-Fine SAFETY Insulin Syringe2026-07-13
K253110 — Sol-Glide Safety Needle; Sol-Glide Safety Needle with Syringe2026-06-18

More clearances from Hlb Lifescience Co., Ltd.

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K241856 — Sofjec (3 models)2024-12-23

Adverse events under product code FMF

product code FMF

Death: 15
Injury: 2,263
Malfunction: 29,722
Other: 17
Total: 32,017

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.