Cleared Traditional

Modular Medical MODD1 Insulin Delivery System

K240158 · Modular Medical, Inc. · Chemistry

Sep 2024

Decision

229d

Days

Class 2

Risk

About This 510(k) Submission

K240158 is an FDA 510(k) clearance for the Modular Medical MODD1 Insulin Delivery System, a Pump, Infusion, Insulin (Class II — Special Controls, product code LZG), submitted by Modular Medical, Inc. (San Diego, US). The FDA issued a Cleared decision on September 4, 2024, 229 days after receiving the submission on January 19, 2024. This device falls under the Chemistry review panel. Regulated under 21 CFR 880.5725.

Submission Details

510(k) Number	K240158 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 19, 2024
Decision Date	September 04, 2024
Days to Decision	229 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF