Cleared Special

K041317 - MODIFICATION TO MEDTRONIC MINIMED PARADIGM MODEL 512 INSULIN PUMP

K041317 is an FDA 510(k) clearance for MODIFICATION TO MEDTRONIC MINIMED PARAD..., 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 62-day FDA review.

K041317 · Medtronic Minimed · General Hospital
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Jul 2004
Decision
62d
Days
Class 2
Risk

K041317 is an FDA 510(k) clearance for the MODIFICATION TO MEDTRONIC MINIMED PARADIGM MODEL 512 INSULIN PUMP. 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 July 19, 2004 after a review of 62 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.

FDA 510(k) Submission Details - K041317

510(k) Number K041317 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 2004
Decision Date July 19, 2004
Days to Decision 62 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
67d faster than avg
Panel avg: 129d · This submission: 62d
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 K041317.
IXL-II DIABETES MANAGEMENT SYSTEM
K042792 · Insulet Corporation · Jan 2005
ANIMAS MODEL IR1250 INSULIN INFUSION PUMP
K042873 · Animas Corp. · Dec 2004
MODIFICATION TO D-TRONPLUS
K043000 · Disetronic Medical Systems AG · Dec 2004
MEDTRONIC MINIMED PARADIGM MODEL 511 INSULIN PUMP
K041318 · Medtronic Minimed · Jul 2004
SMITHS MEDICAL INSULIN INFUSION PUMP WITH COZMONITOR GLUCOSE METER
K031738 · Smiths Medical MD, Inc. · May 2004
MEDTRONIC MINIMED PARADIGM INSULIN PUMP, MODELS MMT-515 AND MMT-715
K040676 · Medtronic Minimed · May 2004
K041317 · MODIFICATION TO MEDTRONIC MINIMED PARADIGM MODEL 512 INSULIN PUMP
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