Cleared Traditional

K160056 - t:slim Insulin Delivery System

K160056 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 195-day FDA review.

K160056 · Tandem Diabetes Care, Inc. · General Hospital
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Jul 2016
Decision
195d
Days
Class 2
Risk

K160056 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. (San Diego, US). The FDA issued a Cleared decision on July 25, 2016 after a review of 195 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

FDA 510(k) Submission Details - K160056

510(k) Number K160056 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 12, 2016
Decision Date July 25, 2016
Days to Decision 195 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
66d slower than avg
Panel avg: 129d · This submission: 195d
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 K160056.
Omnipod DASH Insulin Management System
K180045 · Insulet Corporation · Jun 2018
OmniPod Insulin Management System
K162296 · Insulet Corporation · Apr 2017
t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device Updater
K162080 · Tandem Diabetes Care, Inc. · Oct 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
t:flex Insulin Delivery System
K143189 · Tandem Diabetes Care, Inc. · Jan 2015