Cleared Abbreviated

K080227 - ACCU-CHEK 360 DIABETES MANAGEMENT SYSTEM

K080227 is an FDA 510(k) clearance for ACCU-CHEK 360 DIABETES MANAGEMENT SYSTEM, manufactured by Roche Diagnostics Corp.. The device is a Class 2 General Hospital device with product code MRZ cleared through the Abbreviated 510(k) pathway after a 106-day FDA review.

K080227 · Roche Diagnostics Corp. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2008
Decision
106d
Days
Class 2
Risk

K080227 is an FDA 510(k) clearance for the ACCU-CHEK 360 DIABETES MANAGEMENT SYSTEM. Classified as Accessories, Pump, Infusion (product code MRZ), Class II - Special Controls.

Submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on May 15, 2008 after a review of 106 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

FDA 510(k) Submission Details - K080227

510(k) Number K080227 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 30, 2008
Decision Date May 15, 2008
Days to Decision 106 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
23d faster than avg
Panel avg: 129d · This submission: 106d
Pathway characteristics
Standards-based clearance path.

MRZ Device Classification - Class 2, Special Controls

Product Code MRZ Accessories, Pump, Infusion
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 - MRZ Accessories, Pump, Infusion

All 47
Devices cleared under the same product code (MRZ) and FDA review panel - the closest regulatory comparables to K080227.
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K080227 · ACCU-CHEK 360 DIABETES MANAGEMENT SYSTEM
Download PDF FDA Summary Roche Diagnostics Cor…