Cleared Traditional

K042792 - IXL-II DIABETES MANAGEMENT SYSTEM

K042792 is an FDA 510(k) clearance for IXL-II DIABETES MANAGEMENT SYSTEM, manufactured by Insulet Corporation. The device is a Class 2 General Hospital device with product code LZG cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K042792 · Insulet Corporation · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2005
Decision
89d
Days
Class 2
Risk

K042792 is an FDA 510(k) clearance for the IXL-II DIABETES MANAGEMENT SYSTEM. Classified as Pump, Infusion, Insulin (product code LZG), Class II - Special Controls.

Submitted by Insulet Corporation (Bedford, US). The FDA issued a Cleared decision on January 3, 2005 after a review of 89 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 Insulet Corporation devices

FDA 510(k) Submission Details - K042792

510(k) Number K042792 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 06, 2004
Decision Date January 03, 2005
Days to Decision 89 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
40d faster than avg
Panel avg: 129d · This submission: 89d
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 58
Devices cleared under the same product code (LZG) and FDA review panel - the closest regulatory comparables to K042792.
BIOVALVE INSULIN DELIVERY SYSTEMS (BIDS)
K050971 · Biovalve Technologies, Inc. · Aug 2005
AMIGO INSULIN PUMP
K050312 · Nipro Diabetes Systems, Inc. · May 2005
ACCU-CHEK SPIRIT
K042887 · Disetronic Medical Systems AG · Mar 2005
ANIMAS MODEL IR1250 INSULIN INFUSION PUMP
K042873 · Animas Corp. · Dec 2004
MODIFICATION TO D-TRONPLUS
K043000 · Disetronic Medical Systems AG · Dec 2004
MODIFICATION TO MEDTRONIC MINIMED PARADIGM MODEL 512 INSULIN PUMP
K041317 · Medtronic Minimed · Jul 2004