Cleared Traditional

K152879 - Sure-Fine Insulin Syringes

K152879 is an FDA 510(k) clearance for Sure-Fine Insulin Syringes, manufactured by Shina Med Corporation. The device is a Class 2 General Hospital device with product code FMF cleared through the Traditional 510(k) pathway after a 345-day FDA review.

K152879 · Shina Med Corporation · General Hospital
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Optimized for regulatory review, auditing and printing
Sep 2016
Decision
345d
Days
Class 2
Risk

K152879 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 September 9, 2016 after a review of 345 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5860 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Shina Med Corporation devices

FDA 510(k) Submission Details - K152879

510(k) Number K152879 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2015
Decision Date September 09, 2016
Days to Decision 345 days
Submission Type Traditional
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
216d slower than avg
Panel avg: 129d · This submission: 345d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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

LK Consulting Group USA, Inc.
PRISCILLA 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.

Regulatory Peers - FMF Syringe, Piston

All 549
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K152879.
BD 1ml Luer-lok Hypodermic Syringe, BD 1 mL Luer-Lok Hypodermic Syringe with BD Hypodermic Needle or BD Eclipse Hypodermic Needle, BD 1ml Luer-lok Insulin Syringe
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NovoPen Echo
K162602 · Novo Nordisk, Inc. · Oct 2016
Bone Solutions Mixing and Delivery System
K161568 · Bone Solutions, Inc. · Sep 2016
InPen
K160629 · Companion Medical, Inc. · Jul 2016
SUNGSHIM STERILE SINGLE USE INSULIN SYRINGE
K152803 · Sung Shim Medicare Co., Ltd. · Jul 2016
BD U-500 INSULIN SYRINGE
K151870 · Becton, Dickinson and Company · Jul 2016