510(k) clearance

Pivot Insulin Delivery System

FDA 510(k) source

510(k) number

K262153

Applicant

Modular Medical, Inc.

Decision date

Sep 2, 2026

Date received

Jun 26, 2026

Decision

Substantially Equivalent

Clearance type

Traditional

Product code

LZG

Device type

Pump, Infusion, Insulin

Device class

Class II

Regulation

21 CFR 880.5725

Advisory committee

General Hospital

Statement or summary

Summary

Third party

N

Location

San Diego, CA, US