Cleared Special

K171230 - My Dose Coach

K171230 is an FDA 510(k) clearance for My Dose Coach, manufactured by Sanofi. The device is a Class 2 General Hospital device with product code NDC cleared through the Special 510(k) pathway after a 29-day FDA review.

K171230 · Sanofi · General Hospital
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May 2017
Decision
29d
Days
Class 2
Risk

K171230 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 (Cambridge, US). The FDA issued a Cleared decision on May 26, 2017 after a review of 29 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 868.1890 - the FDA general hospital device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K171230

510(k) Number K171230 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 2017
Decision Date May 26, 2017
Days to Decision 29 days
Submission Type Special
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
100d faster than avg
Panel avg: 129d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

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 K171230.
Glucommander
K152300 · Glytec, LLC · Aug 2017
Insulia Diabetes Management Companion
K170669 · Voluntis Sa. · Jun 2017
Insulin Algorithms System
K160673 · Insulin Algorithms · Jun 2017
My Dose Coach
K163099 · Sanofi, Inc. · Mar 2017
iSage Rx (iSage Rx Basal Insulin Titration)
K161865 · Isag Rx, Inc. · Mar 2017
Go Dose System
K160949 · Eli Lilly and Company · Dec 2016
K171230 · My Dose Coach
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