Cleared Special

K253112 - Sofjec (Single use Needle)

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

K253112 is an FDA 510(k) clearance for Sofjec (Single use Needle), manufactured by Hlb Lifescience Co., Ltd.. The device is a Class 2 General Hospital device with product code FMF cleared through the Special 510(k) pathway after a 239-day FDA review.

K253112 · Hlb Lifescience Co., Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2026
Decision
239d
Days
Class 2
Risk

K253112 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-Si, KR). The FDA issued a Cleared decision on May 21, 2026 after a review of 239 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

FDA 510(k) Submission Details - K253112

510(k) Number K253112 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 2025
Decision Date May 21, 2026
Days to Decision 239 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
110d slower than avg
Panel avg: 129d · This submission: 239d
Pathway characteristics
Modification to existing cleared device.

FMF Device Classification - Class 2, Special Controls

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 Consultant

Mediguide, Inc.
Yongjun Lee

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - FMF Syringe, Piston

All 480
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K253112.
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