Cleared Special

K133593 - T:SLIM INSULIN DELIVERY SYSTEM

K133593 is an FDA 510(k) clearance for T:SLIM INSULIN DELIVERY SYSTEM, manufactured by Tandem Diabetes Care, Inc.. The device is a Class 2 General Hospital device with product code LZG cleared through the Special 510(k) pathway after a 122-day FDA review.

K133593 · Tandem Diabetes Care, Inc. · General Hospital
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Mar 2014
Decision
122d
Days
Class 2
Risk

K133593 is an FDA 510(k) clearance for the T:SLIM INSULIN DELIVERY SYSTEM. Classified as Pump, Infusion, Insulin (product code LZG), Class II - Special Controls.

Submitted by Tandem Diabetes Care, Inc. (Philedelphia, US). The FDA issued a Cleared decision on March 24, 2014 after a review of 122 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Tandem Diabetes Care, Inc. devices

FDA 510(k) Submission Details - K133593

510(k) Number K133593 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 22, 2013
Decision Date March 24, 2014
Days to Decision 122 days
Submission Type Special
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
7d faster than avg
Panel avg: 129d · This submission: 122d
Pathway characteristics
Modification to existing cleared device.

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 58
Devices cleared under the same product code (LZG) and FDA review panel - the closest regulatory comparables to K133593.
Snap Insulin Pump System
K142619 · Asante Solutions, Inc. · Dec 2014
OMNIPOD INSULIN MANAGEMENT SYSTEM
K140439 · Insulet Corporation · Nov 2014
T:SLIM INSULIN DELIVERY SYSTEM
K141758 · Tandem Diabetes Care, Inc. · Oct 2014
OMNIPOD INSULIN MANAGEMENT SYSTEM
K131294 · Insulet Corporation · Aug 2013
PEARL DIABETES MANAGEMENT SYSTEM
K122483 · Asante Solutions, Inc. · Jan 2013
OMNIPOD INSULIN MANAGMENT SYSTEM
K122953 · Insulet Corporation · Dec 2012