Getinge Assured MI Steam Migrating Integrator

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K200252 ↗

FDA Product Code

JOJ

Device Class

Class II

Regulation

21 CFR Part 880.2800

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

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See all devices from Steritec Products Mfg. Co., Inc. →

• What is the Getinge Assured MI Steam Migrating Integrator used for?

  The Getinge Assured MI Steam Migrating Integrator is an internal pack integrating indicator designed to react to critical process parameters of a steam sterilization cycle within a stated tolerance. It provides clear blue Pass/Fail results during steam sterilization.

• How does the Getinge Assured MI Steam Migrating Integrator work?

  During steam sterilization, the chemical pellet inside the device melts and migrates as a blue color along the paper wick. This visual indicator helps users determine whether the sterilization cycle has met the required parameters.

• What is the regulatory status of the Getinge Assured MI Steam Migrating Integrator?

  The device has FDA 510(k) clearance with product code JOJ and is classified as a Class 2 device for Physical/Chemical Sterilization Process and General Hospital use. It is manufactured by Steritec Products Mfg Co, Inc.

• What type of indicator is the Getinge Assured MI Steam Migrating Integrator according to international standards?

  The Getinge Assured MI Steam Migrating Integrator is a Type 5 Integrating Indicator according to ISO 11140-1, which means it provides a comprehensive assessment of the sterilization process by reacting to multiple critical parameters.