Cleared Traditional

K103825 - V-GO INSULIN DELIVERY SYSTEM

K103825 is an FDA 510(k) clearance for V-GO INSULIN DELIVERY SYSTEM, manufactured by Valeritas, Inc.. The device is a Class 2 General Hospital device with product code LZG cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K103825 · Valeritas, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2011
Decision
55d
Days
Class 2
Risk

K103825 is an FDA 510(k) clearance for the V-GO INSULIN DELIVERY SYSTEM. Classified as Pump, Infusion, Insulin (product code LZG), Class II - Special Controls.

Submitted by Valeritas, Inc. (Shrewsbury, US). The FDA issued a Cleared decision on February 23, 2011 after a review of 55 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.

FDA 510(k) Submission Details - K103825

510(k) Number K103825 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 30, 2010
Decision Date February 23, 2011
Days to Decision 55 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
74d faster than avg
Panel avg: 129d · This submission: 55d
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 83
Devices cleared under the same product code (LZG) and FDA review panel - the closest regulatory comparables to K103825.
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
PEARL DIABETES MANAGEMENT SYSTEM
K100567 · M2 Group Holdings, Inc. · May 2011
V-GO DISPOSABLE INSULIN DELIVERY DEVICE, MODEL# V-GO 20, V-GO 30, V-GO40
K100504 · Valeritas, LLC · Dec 2010
SOLO MICROPUMP INSULIN DELIVERY SYSTEM
K093364 · Medingo , Ltd. · Jan 2010
SOLO INSULIN PATCH PUMP
K090245 · Medingo , Ltd. · Jul 2009
K103825 · V-GO INSULIN DELIVERY SYSTEM
Download PDF FDA Summary Valeritas, Inc.