Cleared Special

Sofjec (Single use Needle) (K241856) - FDA 510(k) Clearance

Also marketed or referenced as:
Sofjec (Single use Syringe with or without Needle) Sofjec (Membrane Filter Syringe)

Class II General Hospital device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K241856 · Hlb Lifescience Co., Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2024
Decision
179d
Days
Class 2
Risk

K241856 is an FDA 510(k) clearance for the Sofjec (Single use Needle). Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Hlb Lifescience Co., Ltd. (Anseong, KR). The FDA issued a Cleared decision on December 23, 2024 after a review of 179 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5860 - the FDA general hospital device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Hlb Lifescience Co., Ltd. devices

Submission Details

510(k) Number K241856 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 27, 2024
Decision Date December 23, 2024
Days to Decision 179 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
50d slower than avg
Panel avg: 129d · This submission: 179d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code FMF Syringe, Piston
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5860
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - FMF Syringe, Piston

All 239
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K241856.
GO-PEN®
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K243580 · SurGenTec, LLC · Feb 2025
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Sol-M™ Slip Tip Syringe without Needle, Sol-M™ Eccentric Tip Syringe without Needle
K242099 · Sol-Millennium Medical, Inc. · Oct 2024
Luer Lock Syringe with Safety Needle
K241821 · Sol-Millennium Medical, Inc. · Sep 2024
Tamper Evident Cap
K231095 · International Medical Industries, Inc. · Sep 2024