Skip to content

MiniMed 530G System

by Medtronic, Inc.

PMA P120010

Active United States

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

PMA P120010↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA PMA, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPPR Approved NumberP120010 Date26 Sep 2013ApprovedStatusActive

Recalls

2 recalls · 1 ongoing · FDA

    • Ongoing Z-1751-2026 FDA Class II initiated 13 Feb 2026

    All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of insulin when the pump is elevated or lowered relative to the infusion site, respectively, because of changes in gravitational force impacting hydrostatic and hydrodynamic pressures. Insulin over-delivery, which can occur when the pump is elevated relative to the infusion site, can result in severe hypoglycemia, altered mental status, seizure, coma, or death. An under-delivery of insulin, which can occur at lowered pump height conditions relative to the infusion site, can result in severe hyperglycemia, dehydration, diabetic ketoacidosis, or death.

    • Terminated Z-2544-2014 FDA Class II initiated 13 Mar 2014 on shared PMA P120010

    Medtronic is recalling the Medtronic MiniMed Paradigm Insulin Infusion Pumps because they have received reports that users have accidentally programmed the pump to deliver the maximum bolus amount.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA PMA Active

Specification

PMA

Generic Name
Automated insulin dosing, threshold suspend
PMA Number
FDA Product Code
OZO
Device Class
Class III
Advisory Committee
Clinical Chemistry
FDA Decision
APPR Approved

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The MiniMed 530G System is an automated insulin dosing device with threshold suspend functionality, intended for the continuous delivery of basal insulin at user-selectable rates and administration of insulin boluses in user-selectable amounts for the management of diabetes mellitus in persons aged sixteen years and older requiring insulin. It also provides continuous monitoring and trending of glucose levels in the fluid under the skin.

The system can be programmed to automatically suspend insulin delivery when the sensor glucose value falls below a predefined threshold. It is supplied as a reusable system with disposable components, intended for use in home or clinical settings under medical supervision, and has received FDA PMA authorization (P120010).

Other devices from Medtronic, Inc.

See all devices from Medtronic, Inc. →

Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What age group is the MiniMed 530G System intended for?

    The MiniMed 530G System is intended for persons sixteen years of age and older who require insulin for the management of diabetes mellitus, as stated in the approval documentation.

  • Does the MiniMed 530G System automatically stop insulin delivery under certain conditions?

    Yes, the system can be programmed to automatically suspend delivery of insulin when the sensor glucose value falls below a predefined threshold value, as specified in the approval order.

  • What type of authorization does the MiniMed 530G System have?

    The MiniMed 530G System has received FDA PMA (Premarket Approval) authorization, with application number P120010, as indicated in the device data.