Pivot Insulin Delivery System

FDA 510(k) K262153 · Modular Medical, Inc.

Substantially Equivalent

510(k) numberK262153

Submission

Device name
Pivot Insulin Delivery System
Applicant
Modular Medical, Inc.
San Diego, CA, US
Received
June 26, 2026
Decision date
September 2, 2026
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
LZG – Pump, Infusion, Insulin
Device class
Class II (moderate risk)
Regulation
21 CFR 880.5725
Specialty
General Hospital

Other 510(k)s with product code LZG

510(k)DeviceApplicantDecision
K253534Pivot Insulin Delivery SystemLZG · Traditional Modular Medical04/08/2026SE
K240158Modular Medical MODD1 Insulin Delivery SystemLZG · Traditional Modular Medical, Inc.09/04/2024SE
K241622Extended Reservoir; MiniMed ReservoirLZG · Special Medtronic Minimed07/02/2024SE
K223372Omnipod GO Insulin Delivery DeviceLZG · Traditional Insulet Corporation04/24/2023SE
K210714Extended ReservoirLZG · Traditional Medtronic Minimed, Inc.04/06/2022SE
K211575Omnipod® Insulin Management System, Omnipod DASH® Insulin Management SystemLZG · Traditional Insulet Corporation08/13/2021SE
K192659Omnipod Insulin Management System, Omnipod DASH Insulin Management SystemLZG · Traditional Insulet Corporation10/21/2019SE
K182630Omnipod Insulin Management System, Omnipod DASH Insulin Management SystemLZG · Traditional Insulet Corporation01/08/2019SE
K180045Omnipod DASH Insulin Management SystemLZG · Traditional Insulet Corporation06/01/2018SE
K162296OmniPod Insulin Management SystemLZG · Traditional Insulet Corporation04/18/2017SE

More from Insulet Corporation

510(k)DeviceDecision
K253534Pivot Insulin Delivery SystemLZG · Traditional 04/08/2026SE
K240158Modular Medical MODD1 Insulin Delivery SystemLZG · Traditional 09/04/2024SE

Questions and answers

When was Pivot Insulin Delivery System cleared by the FDA?

Pivot Insulin Delivery System (K262153) received a 510(k) decision of Substantially Equivalent on September 2, 2026, 68 days after the submission was received.

What is the product code of K262153?

The FDA product code is LZG – Pump, Infusion, Insulin, a Class II (moderate risk) device regulated under 21 CFR 880.5725.