Cleared Traditional

K060876 - ACCU-CHEK INSULIN PUMP CONFIGURATION SOFTWARE (STANDARD), MODEL 04625137001

Also marketed or referenced as:
ACCU-CHEK INSULIN PUMP CONFIGURATION SOFTWA

K060876 is an FDA 510(k) clearance for ACCU-CHEK INSULIN PUMP CONFIGURATION SO..., manufactured by Disetronic Medical Systems AG. The device is a Class 2 General Hospital device with product code LZG cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K060876 · Disetronic Medical Systems AG · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2006
Decision
76d
Days
Class 2
Risk

K060876 is an FDA 510(k) clearance for the ACCU-CHEK INSULIN PUMP CONFIGURATION SOFTWARE (STANDARD), MODEL 04625137001. Classified as Pump, Infusion, Insulin (product code LZG), Class II - Special Controls.

Submitted by Disetronic Medical Systems AG (Indianapolis, US). The FDA issued a Cleared decision on June 15, 2006 after a review of 76 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 Disetronic Medical Systems AG devices

FDA 510(k) Submission Details - K060876

510(k) Number K060876 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 2006
Decision Date June 15, 2006
Days to Decision 76 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
53d faster than avg
Panel avg: 129d · This submission: 76d
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 K060876.
PARADIGM INSULIN INFUSION PUMP, MODELS MMT-512, MMT-712, MMT-515 AND MMT-715
K073356 · Medtronic Minimed · Apr 2008
AVIATOR INSULIN PUMP
K071788 · Abbott Diabetes Care, Inc. · Jan 2008
DELTEC COZMO INSULIN INFUSION PUMP WITH COZMONITOR BLOOD GLUCOSE METER, MODELS 21-1815, 21-1816, 21-1817
K062323 · Smiths Medical MD, Inc. · Nov 2006
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