FDA clears Modular Medical's Pivot Insulin Delivery System

On April 8, 2026, the FDA cleared Modular Medical's Pivot Insulin Delivery System through the 510(k) pathway, under submission number K253534.[1] The FDA database lists the decision as substantially equivalent and files the device under product code LZG, the code for insulin infusion pumps.[1] Modular Medical announced the clearance on April 9 and described Pivot as a tubeless insulin patch pump.[3]

What the FDA cleared

A 510(k) clearance is the FDA's finding that a new device is substantially equivalent to a device already legally on the market, which lets the company sell it.[2] For Pivot, the comparison device (the "predicate") was Modular Medical's own MODD1 Insulin Delivery System, cleared earlier under K240158.[2] The 510(k) summary calls Pivot a modified, rebranded MODD1 and says the indications for use did not change.[2]

Those indications are short. Pivot is cleared for delivering insulin under the skin at set and variable rates to manage diabetes in people who need insulin, for individuals 18 years of age and older.[2]

Most of the changes from MODD1 concern the parts that attach to the body. The summary lists four:[2]

• a new Integrated Infusion Set that replaces the separate infusion set and adhesive pad
• a reusable Pivot Inserter that places the new set under the skin, in place of the earlier Orbit Inserter accessory
• a revised insulin cartridge connection that couples directly to the new set
• updated packaging

How the system works, according to the summary

The summary splits Pivot into reusable and single-use parts.[2] The reusable pump is software-controlled and moves insulin with a gear motor and pistons, the same mechanism MODD1 used.[2] Each single-use cartridge holds 3.0 mL (300 units) of insulin and has a built-in battery that powers the pump.[2] A phone app, the Pivot Diabetes App, sets up the basal schedule (the steady background delivery) and sends it to the pump.[2] The summary names Humalog U-100 as the compatible insulin.[2]

The delivery ranges carried over unchanged. The summary gives basal rates of 0.5 to 4 units per hour and bolus doses of 2 to 20 units, chosen in 2-unit steps, and says both match MODD1.[2] The software checks insulin output with redundant sensors. It raises alarms for problems such as a blocked line (an occlusion), a malfunction or a low reservoir.[2]

The evidence FDA reviewed was laboratory and usability work. The summary lists sterility, biocompatibility, adhesive wear, inserter reliability, delivery accuracy and human factors testing, among others.[2] It does not describe a clinical study, and it does not describe a link to a continuous glucose monitor or automated insulin delivery (AID).[2] In its April 9 release, Modular Medical said software enhancements, including AID compatibility, were in development.[3]

What Modular Medical said about launch

On April 9, the company said it planned initial customer shipments by the end of the second quarter of 2026.[3] On June 24, it said Pivot was commercially available in the United States and that first shipments were beginning that week.[4]

On August 3, Modular Medical announced plans to start the first phase of its commercial rollout in October 2026 in five US markets: Atlanta, Cincinnati/Lexington, Dallas, Houston and Philadelphia.[5] On September 3, it said the FDA had cleared a set of Pivot software enhancements, including a way to customize the amount of insulin delivered with each button push.[6] That release gave no 510(k) number, so we have not matched it to an FDA record.

What this means for you

The cleared Pivot system is for adults 18 and older who need insulin.[2] Modular Medical said shipments began in June 2026 and that a five-market rollout would start in October 2026.[4][5] The company pointed people who want more information to PivotPump.com.[4]

Talk to your care team or pharmacist.