Cleared Special

K073356 - PARADIGM INSULIN INFUSION PUMP, MODELS MMT-512, MMT-712, MMT-515 AND MMT-715

K073356 is an FDA 510(k) clearance for PARADIGM INSULIN INFUSION PUMP, manufactured by Medtronic Minimed. The device is a Class 2 General Hospital device with product code LZG cleared through the Special 510(k) pathway after a 148-day FDA review.

K073356 · Medtronic Minimed · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (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.

FDA 510(k) Submission Details - K073356

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
19d slower than avg
Panel avg: 129d · This submission: 148d
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 84
Devices cleared under the same product code (LZG) and FDA review panel - the closest regulatory comparables to K073356.
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NILIMEDIX ADI
K070844 · Nilimedix , Ltd. · Jun 2008
AVIATOR INSULIN PUMP
K071788 · Abbott Diabetes Care, Inc. · Jan 2008
AMIGO INSULIN PUMP
K071613 · Nipro Diabetes Systems, Inc. · Dec 2007
EZMANAGER MAX DIABETES MANAGEMENT SOFTWARE
K063674 · Animas Corp. · Mar 2007
K073356 · PARADIGM INSULIN INFUSION PUMP, MODELS MMT-512, MMT-712, MMT-515 AND MMT-715
Download PDF FDA Summary Medtronic Minimed