Cleared Special

K250510 - Sure-Fine Insulin Syringes (FDA 510(k) Clearance)

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

K250510 · Shina Med Corporation · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2025
Decision
236d
Days
Class 2
Risk

K250510 is an FDA 510(k) clearance for the Sure-Fine Insulin Syringes. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Shina Med Corporation (Anseong-Si, KR). The FDA issued a Cleared decision on October 15, 2025 after a review of 236 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 Shina Med Corporation devices

Submission Details

510(k) Number K250510 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 21, 2025
Decision Date October 15, 2025
Days to Decision 236 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
108d slower than avg
Panel avg: 128d · This submission: 236d
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 Consultant

Plusglobal
Peter Chung

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.

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