Cleared Traditional

K100504 - V-GO DISPOSABLE INSULIN DELIVERY DEVICE, MODEL# V-GO 20, V-GO 30, V-GO40

K100504 is an FDA 510(k) clearance for V-GO DISPOSABLE INSULIN DELIVERY DEVICE, manufactured by Valeritas, LLC. The device is a Class 2 General Hospital device with product code LZG cleared through the Traditional 510(k) pathway after a 282-day FDA review.

K100504 · Valeritas, LLC · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2010
Decision
282d
Days
Class 2
Risk

K100504 is an FDA 510(k) clearance for the V-GO DISPOSABLE INSULIN DELIVERY DEVICE, MODEL# V-GO 20, V-GO 30, V-GO40. Classified as Pump, Infusion, Insulin (product code LZG), Class II - Special Controls.

Submitted by Valeritas, LLC (Shrewsbury, US). The FDA issued a Cleared decision on December 1, 2010 after a review of 282 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 Valeritas, LLC devices

FDA 510(k) Submission Details - K100504

510(k) Number K100504 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 2010
Decision Date December 01, 2010
Days to Decision 282 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
153d slower than avg
Panel avg: 129d · This submission: 282d
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 50
Devices cleared under the same product code (LZG) and FDA review panel - the closest regulatory comparables to K100504.
MEDTRONIC MINIMED PARADIGM INSULIN PUMPS
K120206 · Medtronic Minimed · Mar 2012
FREESTYLE GLUCOSE METER INCORPORATED INTO THE OMNIPOD INSULIN MANAGEMENT SYSTEMS
K111669 · Insulet Corporation · Dec 2011
T:SLIM (TM) INSULIN DELIVERY SYSTEM
K111210 · Tandem Diabetes Care, Inc. · Nov 2011
FREESTYLE AVIATOR INSULIN DELIVERY AND BLOOD GLUCOSE MONITORING SYSTEM
K083225 · Abbott Diabetes Care, Inc. · Feb 2009
SYMPHONY METER REMOTE
K082590 · Lifescan, Inc. · Dec 2008
MODIFICATION TO:ACCU-CHEK POCKET COMPASS DIABETES MANAGEMENT SOFTWARE
K082595 · Roche Diagnostics · Oct 2008