Cleared Traditional

K050312 - AMIGO INSULIN PUMP

K050312 is an FDA 510(k) clearance for AMIGO INSULIN PUMP, manufactured by Nipro Diabetes Systems, Inc.. The device is a Class 2 General Hospital device with product code LZG cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K050312 · Nipro Diabetes Systems, Inc. · General Hospital
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May 2005
Decision
90d
Days
Class 2
Risk

K050312 is an FDA 510(k) clearance for the AMIGO INSULIN PUMP. Classified as Pump, Infusion, Insulin (product code LZG), Class II - Special Controls.

Submitted by Nipro Diabetes Systems, Inc. (Miramar, US). The FDA issued a Cleared decision on May 9, 2005 after a review of 90 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. 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 Nipro Diabetes Systems, Inc. devices

FDA 510(k) Submission Details - K050312

510(k) Number K050312 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 2005
Decision Date May 09, 2005
Days to Decision 90 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
39d faster than avg
Panel avg: 129d · This submission: 90d
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 51
Devices cleared under the same product code (LZG) and FDA review panel - the closest regulatory comparables to K050312.
MEDTRONIC MINIMED PARADIGM INSULIN PUMP, MODEL MMT-712E
K053177 · Medtronic Minimed · Jan 2006
INSULIN PUMP
K051041 · Abbott Diabetes Care, Inc. · Dec 2005
ACCU-CHEK POCKET COMPASS DIABETES MANAGEMENT SOFTWARE
K050760 · Roche Diagnostics Corp. · Sep 2005
IXL-II DIABETES MANAGEMENT SYSTEM
K042792 · Insulet Corporation · Jan 2005
MODIFICATION TO MEDTRONIC MINIMED PARADIGM MODEL 512 INSULIN PUMP
K041317 · Medtronic Minimed · Jul 2004
MEDTRONIC MINIMED PARADIGM MODEL 511 INSULIN PUMP
K041318 · Medtronic Minimed · Jul 2004