Cleared Traditional

K093364 - SOLO MICROPUMP INSULIN DELIVERY SYSTEM

K093364 is an FDA 510(k) clearance for SOLO MICROPUMP INSULIN DELIVERY SYSTEM, manufactured by Medingo , Ltd.. The device is a Class 2 General Hospital device with product code LZG cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K093364 · Medingo , Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2010
Decision
89d
Days
Class 2
Risk

K093364 is an FDA 510(k) clearance for the SOLO MICROPUMP INSULIN DELIVERY SYSTEM. Classified as Pump, Infusion, Insulin (product code LZG), Class II - Special Controls.

Submitted by Medingo , Ltd. (Yoqneam, IL). The FDA issued a Cleared decision on January 25, 2010 after a review of 89 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.

View all Medingo , Ltd. devices

FDA 510(k) Submission Details - K093364

510(k) Number K093364 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 2009
Decision Date January 25, 2010
Days to Decision 89 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
40d faster than avg
Panel avg: 129d · This submission: 89d
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 K093364.
MEDTRONIC MINIMED PARADIGM INSULIN PUMPS
K120206 · Medtronic Minimed · Mar 2012
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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