Cleared Traditional

K080587 - EZ MANAGER MAX DIABETES MANAGEMENT SOFTWARE

K080587 is an FDA 510(k) clearance for EZ MANAGER MAX DIABETES MANAGEMENT SOFTWARE, manufactured by Animas Corp.. The device is a Class 2 General Hospital device with product code MRZ cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K080587 · Animas Corp. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2008
Decision
73d
Days
Class 2
Risk

K080587 is an FDA 510(k) clearance for the EZ MANAGER MAX DIABETES MANAGEMENT SOFTWARE. Classified as Accessories, Pump, Infusion (product code MRZ), Class II - Special Controls.

Submitted by Animas Corp. (West Chester, US). The FDA issued a Cleared decision on May 15, 2008 after a review of 73 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Animas Corp. devices

FDA 510(k) Submission Details - K080587

510(k) Number K080587 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 2008
Decision Date May 15, 2008
Days to Decision 73 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
56d faster than avg
Panel avg: 129d · This submission: 73d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MRZ Device Classification - Class 2, Special Controls

Product Code MRZ Accessories, Pump, Infusion
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 - MRZ Accessories, Pump, Infusion

All 24
Devices cleared under the same product code (MRZ) and FDA review panel - the closest regulatory comparables to K080587.
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CADD-SENTRY PRO MEDICATION SAFETY SOFTWARE-ADMINISTRATOR (21-6275), POINT OF CARE (21-6276)
K072955 · Smiths Medical MD, Inc. · Feb 2008
S.P.A.R STERILE AMBULATORY RESERVOIR
K990091 · Faulding Pharmaceutical Co. · Apr 1999
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K980165 · Datrend Systems, Inc. · Apr 1998