Cleared Traditional

K141929 - ACCU-CHEK CONNECT DIABETES MANAGEMENT APP

K141929 is an FDA 510(k) clearance for ACCU-CHEK CONNECT DIABETES MANAGEMENT APP, manufactured by Roche Diagnostics Corporation. The device is a Class 2 General Hospital device with product code NDC cleared through the Traditional 510(k) pathway after a 243-day FDA review.

K141929 · Roche Diagnostics Corporation · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2015
Decision
243d
Days
Class 2
Risk

K141929 is an FDA 510(k) clearance for the ACCU-CHEK CONNECT DIABETES MANAGEMENT APP. Classified as Calculator, Drug Dose (product code NDC), Class II - Special Controls.

Submitted by Roche Diagnostics Corporation (Indianapolis, US). The FDA issued a Cleared decision on March 16, 2015 after a review of 243 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 868.1890 - 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 Roche Diagnostics Corporation devices

FDA 510(k) Submission Details - K141929

510(k) Number K141929 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 16, 2014
Decision Date March 16, 2015
Days to Decision 243 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
114d slower than avg
Panel avg: 129d · This submission: 243d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NDC Device Classification - Class 2, Special Controls

Product Code NDC Calculator, Drug Dose
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1890
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 - NDC Calculator, Drug Dose

All 42
Devices cleared under the same product code (NDC) and FDA review panel - the closest regulatory comparables to K141929.
Insulia Diabetes Management Companion
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ACCU-CHEK Connect Diabetes Management App
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REACH ACCESS TELEMEDICINE DOSE CALCULATOR
K142123 · Reach Health, Inc. · Sep 2014
GLUCOSTABILIZER INSULIN DOSING CALCULATOR
K141321 · Medical Decision Network · Sep 2014
ENDO TOOL GLUCOSE MANAGEMENT SYSTEM (EGMS)
K132547 · Monarch Medical Technologies · Apr 2014