Cleared Special

K142619 - Snap Insulin Pump System

K142619 is an FDA 510(k) clearance for Snap Insulin Pump System, manufactured by Asante Solutions, Inc.. The device is a Class 2 General Hospital device with product code LZG cleared through the Special 510(k) pathway after a 93-day FDA review.

K142619 · Asante Solutions, Inc. · General Hospital
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Dec 2014
Decision
93d
Days
Class 2
Risk

K142619 is an FDA 510(k) clearance for the Snap Insulin Pump System. Classified as Pump, Infusion, Insulin (product code LZG), Class II - Special Controls.

Submitted by Asante Solutions, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on December 18, 2014 after a review of 93 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 Asante Solutions, Inc. devices

FDA 510(k) Submission Details - K142619

510(k) Number K142619 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 2014
Decision Date December 18, 2014
Days to Decision 93 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
36d faster than avg
Panel avg: 129d · This submission: 93d
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 46
Devices cleared under the same product code (LZG) and FDA review panel - the closest regulatory comparables to K142619.
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
OMNIPOD INSULIN MANAGEMENT SYSTEM
K140439 · Insulet Corporation · Nov 2014
T:SLIM INSULIN DELIVERY SYSTEM
K141758 · Tandem Diabetes Care, Inc. · Oct 2014
T:SLIM INSULIN DELIVERY SYSTEM
K133593 · Tandem Diabetes Care, Inc. · Mar 2014