Cleared Traditional

K140439 - OMNIPOD INSULIN MANAGEMENT SYSTEM

K140439 is an FDA 510(k) clearance for OMNIPOD INSULIN 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 265-day FDA review.

K140439 · Insulet Corporation · General Hospital
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Nov 2014
Decision
265d
Days
Class 2
Risk

K140439 is an FDA 510(k) clearance for the OMNIPOD INSULIN 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 November 13, 2014 after a review of 265 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 Corporation devices

FDA 510(k) Submission Details - K140439

510(k) Number K140439 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 21, 2014
Decision Date November 13, 2014
Days to Decision 265 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
136d slower than avg
Panel avg: 129d · This submission: 265d
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 K140439.
t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device Updater
K160482 · Tandem Diabetes Care, Inc. · Jul 2016
OmniPod Insulin Management System
K160252 · Insulet Corporation · Apr 2016
t:flex Insulin Delivery System
K143189 · Tandem Diabetes Care, Inc. · Jan 2015
T:SLIM INSULIN DELIVERY SYSTEM
K141758 · Tandem Diabetes Care, Inc. · Oct 2014
T:SLIM INSULIN DELIVERY SYSTEM
K133593 · Tandem Diabetes Care, Inc. · Mar 2014
OMNIPOD INSULIN MANAGEMENT SYSTEM
K131294 · Insulet Corporation · Aug 2013