Cleared Traditional

InPen System App (MMT-8060 (iOS), MMT-8061 (Android))

K242775 · Medtronic Minimed · Chemistry

Nov 2024

Decision

60d

Days

Class 2

Risk

About This 510(k) Submission

K242775 is an FDA 510(k) clearance for the InPen System App (MMT-8060 (iOS), MMT-8061 (Android)), a Calculator, Drug Dose (Class II — Special Controls, product code NDC), submitted by Medtronic Minimed (Northridge, US). The FDA issued a Cleared decision on November 12, 2024, 60 days after receiving the submission on September 13, 2024. This device falls under the Chemistry review panel. Regulated under 21 CFR 868.1890.

Submission Details

510(k) Number	K242775 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 13, 2024
Decision Date	November 12, 2024
Days to Decision	60 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF