Cleared Traditional

Insulia Bolus Companion

K232451 · Voluntis Sa. · Chemistry
Dec 2023
Decision
120d
Days
Class 2
Risk

About This 510(k) Submission

K232451 is an FDA 510(k) clearance for the Insulia Bolus 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 December 12, 2023, 120 days after receiving the submission on August 14, 2023. This device falls under the Chemistry review panel. Regulated under 21 CFR 868.1890.

Submission Details

510(k) Number K232451 FDA.gov
FDA Decision Cleared SESE
Date Received August 14, 2023
Decision Date December 12, 2023
Days to Decision 120 days
Submission Type Traditional
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