SafeSecure Steam Sterilization Process Indicator - SafeSecure Vaporized Hydrogen Peroxide Sterilization Process Indicator (4211, 4212, 4213)
FDA 510(k)Class II (US FDA 510(k))
by Shenzhen Safesecure Medical Infection Control Tech Co. , Ltd.
Identifiers
- 510(k) Number
- K251991 FDA 510(k)
- FDA Product Code
- JOJ FDA 510(k)
- Models / Variants
- SafeSecure Vaporized Hydrogen Peroxide Sterilization Process Indicator (4211, 4212, 4213) 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 SafeSecure Steam Sterilization Process Indicator and SafeSecure Vaporized Hydrogen Peroxide Sterilization Process Indicator are physical/chemical sterilization process indicators designed to monitor sterilization processes. These indicators help verify that the sterilization parameters have been met during steam and vaporized hydrogen peroxide sterilization cycles.
The devices are supplied by Shenzhen Safesecure Medical Infection Control Tech Co., Ltd. and have received FDA 510(k) clearance with the product code JOJ. They are intended for use in general hospital settings and are classified as Class II medical devices. The indicators are available in multiple model numbers including 4012, 4013, 4014, 4016 for steam sterilization and 4211, 4212, 4213 for vaporized hydrogen peroxide sterilization.
Frequently asked questions
What is the purpose of the SafeSecure Sterilization Process Indicator?
The SafeSecure Sterilization Process Indicator is designed to monitor sterilization processes by verifying that sterilization parameters have been met during steam and vaporized hydrogen peroxide sterilization cycles in hospital settings.
What models are available for the SafeSecure Sterilization Process Indicator?
The indicator is available in multiple model numbers: 4012, 4013, 4014, and 4016 for steam sterilization, and 4211, 4212, and 4213 for vaporized hydrogen peroxide sterilization.
How is the SafeSecure Sterilization Process Indicator supplied?
The SafeSecure Sterilization Process Indicators are supplied by Shenzhen Safesecure Medical Infection Control Tech Co., Ltd. and have received FDA 510(k) clearance with the product code JOJ.
What is the regulatory classification of the SafeSecure Sterilization Process Indicator?
The SafeSecure Sterilization Process Indicator is classified as a Class II medical device intended for use in general hospital settings, with FDA 510(k) clearance under the product code JOJ.
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: SafeSecure Steam Sterilization Process Indicator (4012, 4013, 4014 ..., K251991 - SafeSecure Steam Sterilization Process Indicat..., PDF K251991 SafeSecure Steam Sterilization Process Indicator (4012, 4013 ..., SafeSecure Sterilization Indicator - K251991 | Medical Device Navigator
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K251991 | Class II | Active |
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Manufacturer
Sources (1)
- FDA 510(k) K251991 24 fields · synced Oct 6, 2026