Cleared Traditional

K162080 - t:slim Insulin Delivery System

K162080 is the FDA 510(k) clearance for t:slim Insulin Delivery System by Tandem Diabetes Care, Inc.. It is a Class 2 General Hospital device (product code LZG) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K162080 · Tandem Diabetes Care, Inc. · General Hospital
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Oct 2016
Decision
90d
Days
Class 2
Risk

K162080 is an FDA 510(k) clearance for the t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device.... Classified as Pump, Infusion, Insulin (product code LZG), Class II - Special Controls.

Submitted by Tandem Diabetes Care, Inc. (San Diego, US). The FDA issued a Cleared decision on October 25, 2016 after a review of 90 days - within the typical 510(k) review window.

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 Tandem Diabetes Care, Inc. devices

Submission Details

510(k) Number K162080 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 2016
Decision Date October 25, 2016
Days to Decision 90 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
39d faster than avg
Panel avg: 129d · This submission: 90d
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 30
Devices cleared under the same product code (LZG) and FDA review panel - the closest regulatory comparables to K162080.
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
MEDTRONIC MINIMED PARADIGM INSULIN PUMPS
K120206 · Medtronic Minimed · Mar 2012
FREESTYLE AVIATOR INSULIN DELIVERY AND BLOOD GLUCOSE MONITORING SYSTEM
K083225 · Abbott Diabetes Care, Inc. · Feb 2009