Cleared Traditional

K170669 - Insulia Diabetes Management Companion

K170669 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 105-day FDA review.

K170669 · Voluntis Sa. · General Hospital
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Jun 2017
Decision
105d
Days
Class 2
Risk

K170669 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 June 19, 2017 after a review of 105 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.

View all Voluntis Sa. devices

FDA 510(k) Submission Details - K170669

510(k) Number K170669 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 06, 2017
Decision Date June 19, 2017
Days to Decision 105 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
24d faster than avg
Panel avg: 129d · This submission: 105d
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 50
Devices cleared under the same product code (NDC) and FDA review panel - the closest regulatory comparables to K170669.
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