Cleared Traditional

K162296 - OmniPod Insulin Management System

K162296 is the FDA 510(k) clearance for OmniPod Insulin Management System by Insulet Corporation. It is a Class 2 General Hospital device (product code LZG) cleared through the Traditional 510(k) pathway after a 245-day FDA review.

K162296 · Insulet Corporation · General Hospital
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Apr 2017
Decision
245d
Days
Class 2
Risk

K162296 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 (Billerica, US). The FDA issued a Cleared decision on April 18, 2017 after a review of 245 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

Submission Details

510(k) Number K162296 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 16, 2016
Decision Date April 18, 2017
Days to Decision 245 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
116d slower than avg
Panel avg: 129d · This submission: 245d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 13
Devices cleared under the same product code (LZG) and FDA review panel - the closest regulatory comparables to K162296.
Omnipod Insulin Management System, Omnipod DASH Insulin Management System
K192659 · Insulet Corporation · Oct 2019
Omnipod Insulin Management System, Omnipod DASH Insulin Management System
K182630 · Insulet Corporation · Jan 2019
Omnipod DASH Insulin Management System
K180045 · Insulet Corporation · Jun 2018
ACCU-CHECK COMBO SYSTEM
K111353 · Roche Diagnostics · Jul 2012
MODIFICATION TO:ACCU-CHEK POCKET COMPASS DIABETES MANAGEMENT SOFTWARE
K082595 · Roche Diagnostics · Oct 2008
ACCU-CHEK POCKET COMPASS DIABETES MANAGEMENT SOFTWARE
K050760 · Roche Diagnostics Corp. · Sep 2005