Cleared Traditional

K143189 - t:flex Insulin Delivery System

K143189 is an FDA 510(k) clearance for t:flex 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 65-day FDA review.

K143189 · Tandem Diabetes Care, Inc. · General Hospital
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Jan 2015
Decision
65d
Days
Class 2
Risk

K143189 is an FDA 510(k) clearance for the t:flex 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 January 9, 2015 after a review of 65 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 Tandem Diabetes Care, Inc. devices

FDA 510(k) Submission Details - K143189

510(k) Number K143189 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 05, 2014
Decision Date January 09, 2015
Days to Decision 65 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
64d faster than avg
Panel avg: 129d · This submission: 65d
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 Consultant

Hogan Lovells US LLP
Janice Hogan

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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 K143189.
t:slim Insulin Delivery System
K160056 · Tandem Diabetes Care, Inc. · Jul 2016
t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device Updater
K160482 · Tandem Diabetes Care, Inc. · Jul 2016
OmniPod Insulin Management System
K160252 · Insulet Corporation · Apr 2016
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