Cleared Abbreviated

K111353 - ACCU-CHECK COMBO SYSTEM

K111353 is the FDA 510(k) clearance for ACCU-CHECK COMBO SYSTEM by Roche Diagnostics. It is a Class 2 General Hospital device (product code LZG) cleared through the Abbreviated 510(k) pathway after a 428-day FDA review.

K111353 · Roche Diagnostics · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2012
Decision
428d
Days
Class 2
Risk

K111353 is an FDA 510(k) clearance for the ACCU-CHECK COMBO SYSTEM. Classified as Pump, Infusion, Insulin (product code LZG), Class II - Special Controls.

Submitted by Roche Diagnostics (Indianapolis, US). The FDA issued a Cleared decision on July 17, 2012 after a review of 428 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5725 - the FDA general hospital device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: High-complexity regulatory submission. Standards-verified equivalence. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all Roche Diagnostics devices

Submission Details

510(k) Number K111353 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 2011
Decision Date July 17, 2012
Days to Decision 428 days
Submission Type Abbreviated
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
299d slower than avg
Panel avg: 129d · This submission: 428d
Pathway characteristics
Standards-based clearance path.

Device Classification

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 12
Devices cleared under the same product code (LZG) and FDA review panel - the closest regulatory comparables to K111353.
Omnipod Insulin Management System, Omnipod DASH Insulin Management System
K192659 · Insulet Corporation · Oct 2019
Omnipod Insulin Management System, Omnipod DASH Insulin Management System
K182630 · Insulet Corporation · Jan 2019
Omnipod DASH Insulin Management System
K180045 · Insulet Corporation · Jun 2018
MODIFICATION TO:ACCU-CHEK POCKET COMPASS DIABETES MANAGEMENT SOFTWARE
K082595 · Roche Diagnostics · Oct 2008
ACCU-CHEK POCKET COMPASS DIABETES MANAGEMENT SOFTWARE
K050760 · Roche Diagnostics Corp. · Sep 2005
MODIFIED BETATRON IV INSULIN INFUSION SYSTEM
K900498 · Cardiac Pacemakers, Inc. · Feb 1990