Cleared Traditional

K161433 - Insulia Diabetes Management Companion

K161433 is an FDA 510(k) clearance for Insulia Diabetes Management Companion, manufactured by Voluntis Sa.. The device is a Class 2 General Hospital device with product code NDC cleared through the Traditional 510(k) pathway after a 169-day FDA review.

K161433 · Voluntis Sa. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2016
Decision
169d
Days
Class 2
Risk

K161433 is an FDA 510(k) clearance for the Insulia Diabetes Management Companion. Classified as Calculator, Drug Dose (product code NDC), Class II - Special Controls.

Submitted by Voluntis Sa. (Paris, FR). The FDA issued a Cleared decision on November 9, 2016 after a review of 169 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.

FDA 510(k) Submission Details - K161433

510(k) Number K161433 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 24, 2016
Decision Date November 09, 2016
Days to Decision 169 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
40d slower than avg
Panel avg: 129d · This submission: 169d
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 K161433.
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
ACCU-CHEK Connect Diabetes Management App
K150910 · Roche Diabetes Care, Inc. · Jun 2015
EndoTool SubQ
K142918 · Monarch Medical Technologies · Apr 2015
ACCU-CHEK CONNECT DIABETES MANAGEMENT APP
K141929 · Roche Diagnostics Corporation · Mar 2015
K161433 · Insulia Diabetes Management Companion
Download PDF FDA Summary Voluntis Sa.