Cleared Traditional

K192659 - Omnipod Insulin Management System

K192659 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 26-day FDA review.

K192659 · Insulet Corporation · General Hospital
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Oct 2019
Decision
26d
Days
Class 2
Risk

K192659 is an FDA 510(k) clearance for the Omnipod Insulin Management System, Omnipod DASH Insulin Management System. 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 October 21, 2019 after a review of 26 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Insulet Corporation devices

Submission Details

510(k) Number K192659 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 2019
Decision Date October 21, 2019
Days to Decision 26 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
103d faster than avg
Panel avg: 129d · This submission: 26d
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 29
Devices cleared under the same product code (LZG) and FDA review panel - the closest regulatory comparables to K192659.
Omnipod GO Insulin Delivery Device
K223372 · Insulet Corporation · Apr 2023
Extended Reservoir
K210714 · Medtronic Minimed, Inc. · Apr 2022
Omnipod® Insulin Management System, Omnipod DASH® Insulin Management System
K211575 · Insulet Corporation · Aug 2021
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