Insulia Diabetes Management Companion— 510(k) K170669

Name: FDA 510(k) clearance K170669
Creator: U.S. Food and Drug Administration
Published: 2017-06-19

Substantially Equivalent

Voluntis Sa.

FDA 510(k) clearance K170669 for Insulia Diabetes Management Companion, Substantially Equivalent on 2017-06-19. Applicant: Voluntis Sa.. Device class: 2.

Clearance details

Applicant: Voluntis Sa.
Product code: Code NDC
Device class: Class 2
Regulation: 21 CFR 868.1890
Advisory panel: Anesthesiology
Date received: 2017-03-06
Decision date: 2017-06-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Paris, FR

Download summary PDF View on FDA.gov ↗

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Adverse events under product code NDC

product code NDC

Malfunction: 1,390
Total: 1,390

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K170669

K-number listed on FDA's recall record

Z-0478-2019 — Insulia Diabetes Management CompanionClass II·Terminated·Voluntis·20181008

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K170669.

Data sourced from openFDA. This site is unofficial and independent of the FDA.