Cleared Traditional

K031373 - IXL DIABETES MANAGEMENT SYSTEM

K031373 is an FDA 510(k) clearance for IXL DIABETES MANAGEMENT SYSTEM, manufactured by Insulet Corp.. The device is a Class 2 General Hospital device with product code LZG cleared through the Traditional 510(k) pathway after a 233-day FDA review.

K031373 · Insulet Corp. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2003
Decision
233d
Days
Class 2
Risk

K031373 is an FDA 510(k) clearance for the IXL DIABETES MANAGEMENT SYSTEM. Classified as Pump, Infusion, Insulin (product code LZG), Class II - Special Controls.

Submitted by Insulet Corp. (Beverly, US). The FDA issued a Cleared decision on December 19, 2003 after a review of 233 days - an extended review 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: 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 Insulet Corp. devices

FDA 510(k) Submission Details - K031373

510(k) Number K031373 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 2003
Decision Date December 19, 2003
Days to Decision 233 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
104d slower than avg
Panel avg: 129d · This submission: 233d
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 53
Devices cleared under the same product code (LZG) and FDA review panel - the closest regulatory comparables to K031373.
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
DIABETES DATA MANAGEMENT SYSTEM (DDMS), MODEL 7333
K032164 · Medtronic Minimed · Oct 2003
R1000 SERIES INSULIN PUMP
K993184 · Animas Corp. · Feb 2000
DISETRONIC D-TRON INSULIN INFUSION PUMP
K994186 · Disetronic Medical Systems · Dec 1999