Cleared Traditional

IXL-II DIABETES MANAGEMENT SYSTEM

K042792 · Insulet Corporation · General Hospital
Jan 2005
Decision
89d
Days
Class 2
Risk

About This 510(k) Submission

K042792 is an FDA 510(k) clearance for the IXL-II DIABETES MANAGEMENT SYSTEM, a Pump, Infusion, Insulin (Class II — Special Controls, product code LZG), submitted by Insulet Corporation (Bedford, US). The FDA issued a Cleared decision on January 3, 2005, 89 days after receiving the submission on October 6, 2004. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5725.

Submission Details

510(k) Number K042792 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code LZG — Pump, Infusion, Insulin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5725

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