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STERRAD Chemical Indicator

FDA 510(k)

Class II (US FDA 510(k))

510(k) K921910

by Johnson & Johnson Medical, Inc.

Identifiers

510(k) Number
K921910 FDA 510(k)
FDA Product Code
JOJ FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 880.2800 FDA 510(k)
Regulation Number
880.2800 FDA 510(k)
Advisory Committee
General Hospital FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The STERRAD Chemical Indicator is a device used to monitor sterilization processes by changing color when exposed to hydrogen peroxide, indicating that instruments have been properly sterilized. It is classified as a chemical indicator for physical/chemical sterilization processes.

This device is supplied as a strip and is latex-free. It is used in hospital settings for monitoring sterilization cycles. The STERRAD Chemical Indicator is authorized under FDA 510K clearance with product code JOJ.

Frequently asked questions

What is the STERRAD Chemical Indicator used for?

The STERRAD Chemical Indicator is a device used to monitor sterilization processes by changing color when exposed to hydrogen peroxide, indicating that instruments have been properly sterilized in hospital settings.

How is the STERRAD Chemical Indicator supplied?

The STERRAD Chemical Indicator is supplied as a strip and is latex-free, making it suitable for use in various medical environments where latex allergies may be a concern.

Is the STERRAD Chemical Indicator single-use or reusable?

The STERRAD Chemical Indicator is designed for single-use to ensure accurate monitoring of each sterilization cycle, as the color change indicates exposure to sterilization conditions.

What is the regulatory status of the STERRAD Chemical Indicator?

The STERRAD Chemical Indicator is authorized under FDA 510K clearance with product code JOJ, meaning it has been determined to be substantially equivalent to other legally marketed devices.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Johnson & Johnson STERRAD Chemical Indicators - Sterrad Chemical ..., J&J/Asp Sterrad Chemical Indicators Case 14202 By Johnson & Johnson ..., Johnson & Johnson STERRAD Chemical Indicators - Sterrad Chemical ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Johnson & Johnson Medical, Inc.

Sources (1)

  • FDA 510(k) K921910 24 fields · synced Oct 6, 2026