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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / April 2026 / K253534

510(k) cleared

Pivot Insulin Delivery System

Modular Medical · Apr 8, 2026 · K253534

FDA cleared the Pivot Insulin Delivery System from Modular Medical on Apr 8, 2026 under K253534, 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 Nov 13, 2025. The decision came 146 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Modular Medical in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253534?

K253534 is the FDA 510(k) for Pivot Insulin Delivery System, submitted by Modular Medical. FDA's decision date was Apr 8, 2026, under product code LZG (Pump, Infusion, Insulin).

Who makes the Pivot Insulin Delivery System?

Modular Medical, based in San Diego, CA, is the applicant of record for K253534.

How long did the K253534 review take?

FDA received the submission on Nov 13, 2025 and issued its decision on Apr 8, 2026, 146 days later.

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