Cleared Traditional

K111210 - T:SLIM (TM) INSULIN DELIVERY SYSTEM

K111210 is the FDA 510(k) clearance for T:SLIM (TM) 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 194-day FDA review.

K111210 · Tandem Diabetes Care, Inc. · General Hospital
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Nov 2011
Decision
194d
Days
Class 2
Risk

K111210 is an FDA 510(k) clearance for the T:SLIM (TM) INSULIN DELIVERY SYSTEM. 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 November 9, 2011 after a review of 194 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 Tandem Diabetes Care, Inc. devices

Submission Details

510(k) Number K111210 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 29, 2011
Decision Date November 09, 2011
Days to Decision 194 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
65d slower than avg
Panel avg: 129d · This submission: 194d
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 K111210.
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
SYMPHONY METER REMOTE
K082590 · Lifescan, Inc. · Dec 2008
MODIFICATION TO:ACCU-CHEK POCKET COMPASS DIABETES MANAGEMENT SOFTWARE
K082595 · Roche Diagnostics · Oct 2008