Cleared Traditional

K110882 - IMC INSULIN SYRINGE

K110882 is an FDA 510(k) clearance for IMC INSULIN SYRINGE, manufactured by International Medsurg Connection. The device is a Class 2 General Hospital device with product code FMF cleared through the Traditional 510(k) pathway after a 141-day FDA review.

K110882 · International Medsurg Connection · General Hospital
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Aug 2011
Decision
141d
Days
Class 2
Risk

K110882 is an FDA 510(k) clearance for the IMC INSULIN SYRINGE. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by International Medsurg Connection (Schaumburg, US). The FDA issued a Cleared decision on August 18, 2011 after a review of 141 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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 International Medsurg Connection devices

FDA 510(k) Submission Details - K110882

510(k) Number K110882 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 2011
Decision Date August 18, 2011
Days to Decision 141 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
12d slower than avg
Panel avg: 129d · This submission: 141d
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 Peers - FMF Syringe, Piston

All 316
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K110882.
MONOJECT 12ML SYRINGE
K130049 · Nipro Medical Corporation · Feb 2013
BD EMERALD SAF-T SINGLE USE, HYPODERMIC
K121283 · Becton, Dickinson and Company · May 2012
ARTHREX MIXING AND DELIVERY SYSTEM
K121124 · Arthrex, Inc. · May 2012
MERIT MEDICAL 20 ML SYRINGE
K111091 · Merit Medical Systems, Inc. · Jun 2011
BD SINGLE USE, HYPODERMIC SYRINGE
K110771 · Becton, Dickinson and Company · May 2011
INDISCAL DIGITAL MANOMETER
K102192 · Baylis Medical Co., Inc. · Feb 2011