Cleared Traditional

K072174 - INSUCOZI INSULIN VIAL COVER

K072174 is an FDA 510(k) clearance for INSUCOZI INSULIN VIAL COVER, manufactured by 41 Industries, LLC. The device is a Class 1 General Hospital device with product code IQG cleared through the Traditional 510(k) pathway after a 172-day FDA review.

K072174 · 41 Industries, LLC · General Hospital
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Jan 2008
Decision
172d
Days
Class 1
Risk

K072174 is an FDA 510(k) clearance for the INSUCOZI INSULIN VIAL COVER. Classified as Adaptor, Holder, Syringe (product code IQG), Class I - General Controls.

Submitted by 41 Industries, LLC (Wheat Ridge, US). The FDA issued a Cleared decision on January 25, 2008 after a review of 172 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 890.5050 - 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 41 Industries, LLC devices

FDA 510(k) Submission Details - K072174

510(k) Number K072174 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 2007
Decision Date January 25, 2008
Days to Decision 172 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
43d slower than avg
Panel avg: 129d · This submission: 172d
Pathway characteristics
Predicate-based equivalence.

IQG Device Classification - Class 1, General Controls

Product Code IQG Adaptor, Holder, Syringe
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.5050
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.