Cleared Traditional

K162296 - OmniPod Insulin Management System

K162296 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 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

FDA 510(k) Submission Details - K162296

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
Combination Product No
PCCP Authorized No
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.

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 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
t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device Updater
K162080 · Tandem Diabetes Care, Inc. · Oct 2016
t:slim Insulin Delivery System
K160056 · Tandem Diabetes Care, Inc. · Jul 2016
t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device Updater
K160482 · Tandem Diabetes Care, Inc. · Jul 2016