Cleared Special

K073356 - PARADIGM INSULIN INFUSION PUMP, MODELS MMT-512, MMT-712, MMT-515 AND MMT-715 (FDA 510(k) Clearance)

Class II General Hospital device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K073356 · Medtronic Minimed · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2008
Decision
148d
Days
Class 2
Risk

K073356 is an FDA 510(k) clearance for the PARADIGM INSULIN INFUSION PUMP, MODELS MMT-512, MMT-712, MMT-515 AND MMT-715. Classified as Pump, Infusion, Insulin (product code LZG), Class II - Special Controls.

Submitted by Medtronic Minimed (Northridge, US). The FDA issued a Cleared decision on April 25, 2008 after a review of 148 days - within the typical 510(k) review window.

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 Medtronic Minimed devices

Submission Details

510(k) Number K073356 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 29, 2007
Decision Date April 25, 2008
Days to Decision 148 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
20d slower than avg
Panel avg: 128d · This submission: 148d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 83
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