Cleared Special

K083576 - MISER CONTRAST MANAGEMENT SYSTEM

K083576 is the FDA 510(k) clearance for MISER CONTRAST MANAGEMENT SYSTEM by Merit Medical Systems, Inc.. It is a Class 2 General Hospital device (product code FPA) cleared through the Special 510(k) pathway after a 20-day FDA review.

K083576 · Merit Medical Systems, Inc. · General Hospital
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Dec 2008
Decision
20d
Days
Class 2
Risk

K083576 is an FDA 510(k) clearance for the MISER CONTRAST MANAGEMENT SYSTEM. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Merit Medical Systems, Inc. (South Jordan, US). The FDA issued a Cleared decision on December 23, 2008 after a review of 20 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5440 - 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. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Merit Medical Systems, Inc. devices

Submission Details

510(k) Number K083576 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 03, 2008
Decision Date December 23, 2008
Days to Decision 20 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
109d faster than avg
Panel avg: 129d · This submission: 20d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code FPA Set, Administration, Intravascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5440
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 - FPA Set, Administration, Intravascular

All 416
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UNASSIGNED
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