Cleared Traditional

K013309 - GLUCOPRO EVO INFUSION PUMP

K013309 is an FDA 510(k) clearance for GLUCOPRO EVO INFUSION 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 263-day FDA review.

K013309 · Nipro Diabetes Systems, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2002
Decision
263d
Days
Class 2
Risk

K013309 is an FDA 510(k) clearance for the GLUCOPRO EVO INFUSION PUMP. Classified as Pump, Infusion, Insulin (product code LZG), Class II - Special Controls.

Submitted by Nipro Diabetes Systems, Inc. (Lexington, US). The FDA issued a Cleared decision on June 24, 2002 after a review of 263 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.

FDA 510(k) Submission Details - K013309

510(k) Number K013309 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 04, 2001
Decision Date June 24, 2002
Days to Decision 263 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
134d slower than avg
Panel avg: 129d · This submission: 263d
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 K013309.
DELTEC INSULIN INFUSION PUMP AND ACCESSORIES
K020655 · Deltec, Inc. · Aug 2002
DISETRONIC D-TRON INSULIN INFUSION PUMP
K021725 · Disetronic Medical Systems AG · Aug 2002
DANA DIABECARE II INSULIN PUMP & SUPERLINE-EASYRELEASE, SOFT-RELEASE-ST, & SOFT-RELEASE-R INFUSION SETS
K022317 · Sooil Development Co., Ltd. · Aug 2002
MODEL R1000 IR INSULIN PUMP, EZLINK SOFTWARE, SERMON SOFTWARE, R1000 IR DOWNLOAD CRADLE, AND SERIAL INTERFACE ADAPTOR DO
K021439 · Animas Corp. · May 2002
MICROJET QUARK, MODEL U100 OR U40
K013807 · Cane S.R.L. · Dec 2001
DANA DIABECARE
K001604 · Sooil Development Co., Ltd. · Aug 2000
K013309 · GLUCOPRO EVO INFUSION PUMP
Download PDF FDA Summary Nipro Diabetes System…