FDA cleared the Pivot Insulin Delivery System from Modular Medical, Inc. on Sep 2, 2026 under K262153, a traditional 510(k). The device falls under product code LZG, Pump, Infusion, Insulin, regulated at 21 CFR 880.5725 as a Class 2 device. The review panel was General Hospital.
FDA logged the submission as received on Jun 26, 2026. The decision came 68 days later, inside the 90 FDA-day goal for a 510(k).
Modular Medical, Inc. has one other decision in the tracker over the last 12 months: K253534 (Pivot Insulin Delivery System).
Questions & Answers
What did FDA clear under K262153?
K262153 is the FDA 510(k) for Pivot Insulin Delivery System, submitted by Modular Medical, Inc.. FDA's decision date was Sep 2, 2026, under product code LZG (Pump, Infusion, Insulin).
Who makes the Pivot Insulin Delivery System?
Modular Medical, Inc., based in San Diego, CA, is the applicant of record for K262153. The company is listed in the MedDevice Startups directory.
How long did the K262153 review take?
FDA received the submission on Jun 26, 2026 and issued its decision on Sep 2, 2026, 68 days later.