Cleared Special

K062323 - DELTEC COZMO INSULIN INFUSION PUMP WITH...

K062323 is an FDA 510(k) clearance for DELTEC COZMO INSULIN INFUSION PUMP WITH..., manufactured by Smiths Medical MD, Inc.. The device is a Class 2 General Hospital device with product code LZG cleared through the Special 510(k) pathway after a 84-day FDA review.

K062323 · Smiths Medical MD, Inc. · General Hospital
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Nov 2006
Decision
84d
Days
Class 2
Risk

K062323 is an FDA 510(k) clearance for the DELTEC COZMO INSULIN INFUSION PUMP WITH COZMONITOR BLOOD GLUCOSE METER, MODEL.... Classified as Pump, Infusion, Insulin (product code LZG), Class II - Special Controls.

Submitted by Smiths Medical MD, Inc. (St. Paul, US). The FDA issued a Cleared decision on November 1, 2006 after a review of 84 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 Smiths Medical MD, Inc. devices

FDA 510(k) Submission Details - K062323

510(k) Number K062323 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 2006
Decision Date November 01, 2006
Days to Decision 84 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
45d faster than avg
Panel avg: 129d · This submission: 84d
Pathway characteristics
Modification to existing cleared device.

LZG Device Classification - Class 2, Special Controls

Product Code LZG Pump, Infusion, Insulin
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 - LZG Pump, Infusion, Insulin

All 44
Devices cleared under the same product code (LZG) and FDA review panel - the closest regulatory comparables to K062323.
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