Cleared Special

Insulia Diabetes Management Companion

K202596 · Voluntis Sa. · Chemistry
Jun 2021
Decision
269d
Days
Class 2
Risk

About This 510(k) Submission

K202596 is an FDA 510(k) clearance for the Insulia Diabetes Management Companion, a Calculator, Drug Dose (Class II — Special Controls, product code NDC), submitted by Voluntis Sa. (Suresnes, FR). The FDA issued a Cleared decision on June 4, 2021, 269 days after receiving the submission on September 8, 2020. This device falls under the Chemistry review panel. Regulated under 21 CFR 868.1890.

Submission Details

510(k) Number K202596 FDA.gov
FDA Decision Cleared SESE
Date Received September 08, 2020
Decision Date June 04, 2021
Days to Decision 269 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code NDC — Calculator, Drug Dose
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.1890