Cleared Traditional

K083225 - FREESTYLE AVIATOR INSULIN DELIVERY AND ...

K083225 is an FDA 510(k) clearance for FREESTYLE AVIATOR INSULIN DELIVERY AND ..., manufactured by Abbott Diabetes Care, Inc.. 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.

K083225 · Abbott Diabetes Care, Inc. · General Hospital
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Feb 2009
Decision
109d
Days
Class 2
Risk

K083225 is an FDA 510(k) clearance for the FREESTYLE AVIATOR INSULIN DELIVERY AND BLOOD GLUCOSE MONITORING SYSTEM. Classified as Pump, Infusion, Insulin (product code LZG), Class II - Special Controls.

Submitted by Abbott Diabetes Care, Inc. (Alameda, US). The FDA issued a Cleared decision on February 20, 2009 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 Abbott Diabetes Care, Inc. devices

FDA 510(k) Submission Details - K083225

510(k) Number K083225 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 03, 2008
Decision Date February 20, 2009
Days to Decision 109 days
Submission Type Traditional
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
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 43
Devices cleared under the same product code (LZG) and FDA review panel - the closest regulatory comparables to K083225.
MEDTRONIC MINIMED PARADIGM INSULIN PUMPS
K120206 · Medtronic Minimed · Mar 2012
FREESTYLE GLUCOSE METER INCORPORATED INTO THE OMNIPOD INSULIN MANAGEMENT SYSTEMS
K111669 · Insulet Corporation · Dec 2011
T:SLIM (TM) INSULIN DELIVERY SYSTEM
K111210 · Tandem Diabetes Care, Inc. · Nov 2011
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