Cleared Traditional

K163099 - My Dose Coach

K163099 is an FDA 510(k) clearance for My Dose Coach, manufactured by Sanofi, Inc.. The device is a Class 2 General Hospital device with product code NDC cleared through the Traditional 510(k) pathway after a 135-day FDA review.

K163099 · Sanofi, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2017
Decision
135d
Days
Class 2
Risk

K163099 is an FDA 510(k) clearance for the My Dose Coach. Classified as Calculator, Drug Dose (product code NDC), Class II - Special Controls.

Submitted by Sanofi, Inc. (Cambridge, US). The FDA issued a Cleared decision on March 22, 2017 after a review of 135 days - within the typical 510(k) review window.

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.

FDA 510(k) Submission Details - K163099

510(k) Number K163099 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 07, 2016
Decision Date March 22, 2017
Days to Decision 135 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
6d slower than avg
Panel avg: 129d · This submission: 135d
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 52
Devices cleared under the same product code (NDC) and FDA review panel - the closest regulatory comparables to K163099.
Insulia Diabetes Management Companion
K170669 · Voluntis Sa. · Jun 2017
Insulin Algorithms System
K160673 · Insulin Algorithms · Jun 2017
My Dose Coach
K171230 · Sanofi · May 2017
iSage Rx (iSage Rx Basal Insulin Titration)
K161865 · Isag Rx, Inc. · Mar 2017
Go Dose System
K160949 · Eli Lilly and Company · Dec 2016
Insulia Diabetes Management Companion
K161433 · Voluntis Sa. · Nov 2016
K163099 · My Dose Coach
Download PDF Sanofi, Inc.