Cleared Special

K063288 - SIGNATURE EDITION GOLD INFUSION SYSTEM

K063288 is an FDA 510(k) clearance for SIGNATURE EDITION GOLD INFUSION SYSTEM, manufactured by Cardinal Health 303,Inc.. The device is a Class 2 General Hospital device with product code FRN cleared through the Special 510(k) pathway after a 27-day FDA review.

K063288 · Cardinal Health 303,Inc. · General Hospital
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Nov 2006
Decision
27d
Days
Class 2
Risk

K063288 is an FDA 510(k) clearance for the SIGNATURE EDITION GOLD INFUSION SYSTEM, MODEL 7X3X. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Cardinal Health 303,Inc. (San Diego, US). The FDA issued a Cleared decision on November 28, 2006 after a review of 27 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5725 - 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 Cardinal Health 303,Inc. devices

FDA 510(k) Submission Details - K063288

510(k) Number K063288 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 2006
Decision Date November 28, 2006
Days to Decision 27 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
102d faster than avg
Panel avg: 129d · This submission: 27d
Pathway characteristics
Modification to existing cleared device.

FRN Device Classification - Class 2, Special Controls

Product Code FRN Pump, Infusion
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5725
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 - FRN Pump, Infusion

All 460
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