Cleared Traditional

K063674 - EZMANAGER MAX DIABETES MANAGEMENT SOFTWARE

K063674 is an FDA 510(k) clearance for EZMANAGER MAX DIABETES MANAGEMENT SOFTWARE, manufactured by Animas Corp.. The device is a Class 2 General Hospital device with product code LZG cleared through the Traditional 510(k) pathway after a 109-day FDA review.

K063674 · Animas Corp. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2007
Decision
109d
Days
Class 2
Risk

K063674 is an FDA 510(k) clearance for the EZMANAGER MAX DIABETES MANAGEMENT SOFTWARE. Classified as Pump, Infusion, Insulin (product code LZG), Class II - Special Controls.

Submitted by Animas Corp. (West Chester, US). The FDA issued a Cleared decision on March 30, 2007 after a review of 109 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Animas Corp. devices

FDA 510(k) Submission Details - K063674

510(k) Number K063674 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 11, 2006
Decision Date March 30, 2007
Days to Decision 109 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 129d · This submission: 109d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 50
Devices cleared under the same product code (LZG) and FDA review panel - the closest regulatory comparables to K063674.
MODIFICATION TO:ACCU-CHEK POCKET COMPASS DIABETES MANAGEMENT SOFTWARE
K082595 · Roche Diagnostics · Oct 2008
PARADIGM INSULIN INFUSION PUMP, MODELS MMT-512, MMT-712, MMT-515 AND MMT-715
K073356 · Medtronic Minimed · Apr 2008
AVIATOR INSULIN PUMP
K071788 · Abbott Diabetes Care, Inc. · Jan 2008
DELTEC COZMO INSULIN INFUSION PUMP WITH COZMONITOR BLOOD GLUCOSE METER, MODELS 21-1815, 21-1816, 21-1817
K062323 · Smiths Medical MD, Inc. · Nov 2006
MEDTRONIC MINIMED PARADIGM INSULIN PUMP, MODEL MMT-712E
K053177 · Medtronic Minimed · Jan 2006
INSULIN PUMP
K051041 · Abbott Diabetes Care, Inc. · Dec 2005