Cleared Traditional

K122953 - OMNIPOD INSULIN MANAGMENT SYSTEM

K122953 is an FDA 510(k) clearance for OMNIPOD INSULIN MANAGMENT 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 73-day FDA review.

K122953 · Insulet Corporation · General Hospital
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Dec 2012
Decision
73d
Days
Class 2
Risk

K122953 is an FDA 510(k) clearance for the OMNIPOD INSULIN MANAGMENT 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 December 7, 2012 after a review of 73 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

FDA 510(k) Submission Details - K122953

510(k) Number K122953 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 2012
Decision Date December 07, 2012
Days to Decision 73 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
56d faster than avg
Panel avg: 129d · This submission: 73d
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 K122953.
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
ACCU-CHECK COMBO SYSTEM
K111353 · Roche Diagnostics · Jul 2012
MEDTRONIC MINIMED PARADIGM INSULIN PUMPS
K120206 · Medtronic Minimed · Mar 2012
FREESTYLE GLUCOSE METER INCORPORATED INTO THE OMNIPOD INSULIN MANAGEMENT SYSTEMS
K111669 · Insulet Corporation · Dec 2011