Cleared Traditional

K141758 - T:SLIM INSULIN DELIVERY SYSTEM

K141758 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 Traditional 510(k) pathway after a 123-day FDA review.

K141758 · Tandem Diabetes Care, Inc. · General Hospital
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Oct 2014
Decision
123d
Days
Class 2
Risk

K141758 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 October 31, 2014 after a review of 123 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

FDA 510(k) Submission Details - K141758

510(k) Number K141758 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 30, 2014
Decision Date October 31, 2014
Days to Decision 123 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
6d faster than avg
Panel avg: 129d · This submission: 123d
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 58
Devices cleared under the same product code (LZG) and FDA review panel - the closest regulatory comparables to K141758.
t:flex Insulin Delivery System
K143189 · Tandem Diabetes Care, Inc. · Jan 2015
Snap Insulin Pump System
K142619 · Asante Solutions, Inc. · Dec 2014
OMNIPOD INSULIN MANAGEMENT SYSTEM
K140439 · Insulet Corporation · Nov 2014
T:SLIM INSULIN DELIVERY SYSTEM
K133593 · Tandem Diabetes Care, Inc. · Mar 2014
OMNIPOD INSULIN MANAGEMENT SYSTEM
K131294 · Insulet Corporation · Aug 2013
PEARL DIABETES MANAGEMENT SYSTEM
K122483 · Asante Solutions, Inc. · Jan 2013