Cleared Traditional

K223372 - Omnipod GO Insulin Delivery Device (FDA 510(k) Clearance)

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K223372 · Insulet Corporation · Chemistry device
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Apr 2023
Decision
171d
Days
Class 2
Risk

K223372 is an FDA 510(k) clearance for the Omnipod GO Insulin Delivery Device. Classified as Pump, Infusion, Insulin (product code LZG), Class II - Special Controls.

Submitted by Insulet Corporation (Acton, US). The FDA issued a Cleared decision on April 24, 2023 after a review of 171 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 880.5725 - the FDA in vitro diagnostics and chemistry 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 Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Insulet Corporation devices

Submission Details

510(k) Number K223372 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 04, 2022
Decision Date April 24, 2023
Days to Decision 171 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
83d slower than avg
Panel avg: 88d · This submission: 171d
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 Chemistry devices follow this clearance model.

Regulatory Peers - LZG Pump, Infusion, Insulin

All 83
Devices cleared under the same product code (LZG) and FDA review panel - the closest regulatory comparables to K223372.
Pivot Insulin Delivery System
K253534 · Modular Medical · Apr 2026
Modular Medical MODD1 Insulin Delivery System
K240158 · Modular Medical, Inc. · Sep 2024
Extended Reservoir
K241622 · Medtronic Minimed · Jul 2024
Omnipod® Insulin Management System, Omnipod DASH® Insulin Management System
K211575 · Insulet Corporation · Aug 2021