Sterrad Cyclesure Biological Indicator
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K994055 FDA 510(k)
- FDA Product Code
- FRC 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 Cyclesure Biological Indicator is a biological indicator designed for monitoring the sterilization process of STERRAD systems. It functions as a biological monitor to validate the effectiveness of sterilization cycles by detecting the presence of viable spores, specifically Bacillus stearothermophilus, ensuring microbial inactivation within the sterilizer.
This single-use indicator is supplied as a self-contained plastic vial containing a glass fiber disc impregnated with spores. It is intended for use in general hospital settings and is regulated under FDA 510(k) clearance (K994055) as a Class II device. Sterility is ensured through the biological challenge, and the indicator is not reusable. No MRI safety information is specified, and storage conditions are not detailed in the provided data.
Frequently asked questions
What is the Sterrad Cyclesure Biological Indicator used for?
The Sterrad Cyclesure Biological Indicator is designed to monitor and validate the effectiveness of sterilization cycles in STERRAD systems. It detects viable spores of *Bacillus stearothermophilus*, ensuring that the sterilization process fully inactivates microbial contaminants. This helps hospitals confirm that their sterilization equipment is functioning correctly and maintaining proper sterilization standards.
How is the Sterrad Cyclesure Biological Indicator supplied?
The indicator is supplied as a single-use, self-contained plastic vial containing a glass fiber disc impregnated with spores. Each vial is intended for one-time use in a single sterilization cycle, ensuring accurate and reliable results without cross-contamination.
Is the Sterrad Cyclesure Biological Indicator reusable?
No, the Sterrad Cyclesure Biological Indicator is explicitly designed for single-use only. After one sterilization cycle, the indicator should be discarded to prevent contamination and ensure accurate monitoring of future cycles.
What type of spores does the Sterrad Cyclesure Biological Indicator detect?
The indicator detects viable spores of *Bacillus stearothermophilus*, a microorganism commonly used in biological indicators to challenge sterilization processes. The presence or absence of these spores confirms whether the sterilization cycle achieved the required level of microbial inactivation.
Are there any specific storage instructions for the Sterrad Cyclesure Biological Indicator?
The provided data does not specify storage conditions for the Sterrad Cyclesure Biological Indicator. However, as with most biological indicators, it is generally recommended to store them in a clean, dry environment away from direct sunlight or extreme temperatures until use. Always follow manufacturer guidelines for optimal performance.
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: CYCLESURE® 24 Biological Indicator (BI) | ASP, STERRAD CYCLESURE BIOLOGICAL INDICATOR (K994055) — FDA 510 (k) | Innolitics, What Is Sterrad Sterilization and How Does It Work?
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K994055 | Class II | Active |
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Manufacturer
- Manufacturer
- Advanced Sterilization Products
Sources (1)
- FDA 510(k) K994055 24 fields · synced Oct 1, 2026