Cleared Traditional

K080639 - SYMPHONY GLUCOSE MANAGEMENT SYSTEM

K080639 is an FDA 510(k) clearance for SYMPHONY GLUCOSE MANAGEMENT SYSTEM, 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 110-day FDA review.

K080639 · Animas Corp. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2008
Decision
110d
Days
Class 2
Risk

K080639 is an FDA 510(k) clearance for the SYMPHONY GLUCOSE MANAGEMENT SYSTEM. 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 June 24, 2008 after a review of 110 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 - K080639

510(k) Number K080639 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 06, 2008
Decision Date June 24, 2008
Days to Decision 110 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
19d faster than avg
Panel avg: 129d · This submission: 110d
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 K080639.
FREESTYLE AVIATOR INSULIN DELIVERY AND BLOOD GLUCOSE MONITORING SYSTEM
K083225 · Abbott Diabetes Care, Inc. · Feb 2009
SYMPHONY METER REMOTE
K082590 · Lifescan, Inc. · Dec 2008
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