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
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

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
Combination Product No
PCCP Authorized No
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 83
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
K142619 · Snap Insulin Pump System
Download PDF FDA Summary Asante Solutions, Inc.