Cleared Special

K072105 - ALARIS SYSTEM WITH MMS

K072105 is an FDA 510(k) clearance for ALARIS SYSTEM WITH MMS, 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 150-day FDA review.

K072105 · Cardinal Health 303,Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2007
Decision
150d
Days
Class 2
Risk

K072105 is an FDA 510(k) clearance for the ALARIS SYSTEM WITH MMS, MODEL 8XXX. 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 December 28, 2007 after a review of 150 days - an extended review 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. Standard predicate reliance. 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 - K072105

510(k) Number K072105 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 2007
Decision Date December 28, 2007
Days to Decision 150 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
21d slower than avg
Panel avg: 129d · This submission: 150d
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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