FDA 510(k)

Pivot Insulin Delivery System

N.º K: K253534 · 2026-04-08

Fecha de decisión2026-04-08

Código de productoLZG

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

Pivot Insulin Delivery System is the device name listed in this FDA 510(k) record. The listed applicant is Modular Medical. It received FDA 510(k) clearance on 2026-04-08 under 510(k) number K253534. The device is classified under product code LZG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

¿Qué es el Sistema de Entrega de Insulina Pivot?

Pivot Insulin Delivery System is a medical device that received FDA 510(k) clearance on 2026-04-08. The listed applicant is Modular Medical. The 510(k) number is K253534.

When did Pivot Insulin Delivery System receive FDA 510(k) clearance?

Pivot Insulin Delivery System received FDA 510(k) clearance on 2026-04-08, under 510(k) number K253534.

Who is the listed applicant for Pivot Insulin Delivery System?

The FDA 510(k) record lists Modular Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Pivot Insulin Delivery System?

The FDA product code for Pivot Insulin Delivery System is LZG.

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Dispositivos relacionados (Código: LZG)

K262153Pivot Insulin Delivery SystemModular Medical, Inc.K240158Modular Medical MODD1 Insulin Delivery SystemModular Medical, Inc.K241622Extended Reservoir; MiniMed ReservoirMedtronic Minimed K223372Omnipod GO Insulin Delivery DeviceInsulet Corporation K210714Extended ReservoirMedtronic Minimed, Inc.K211575Omnipod® Insulin Management System, Omnipod DASH® Insulin Management SystemInsulet Corporation

Fuente oficial

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