Sterrad Velocity Biological Indicator and Reader
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K170039 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 Velocity Biological Indicator and Reader is a Biological Sterilization Process Indicator designed to validate the effectiveness of sterilization cycles in hydrogen peroxide-based systems. It combines a biological indicator (BI) with a process challenge device (PCD) to provide real-time verification of microbial kill, ensuring sterility assurance for medical instruments and devices processed in Sterrad systems.
This system consists of a Biological Indicator/Process Challenge Device (BI/PCD) and a dedicated reader, operating exclusively with Sterrad sterilizers. It is intended for single-use applications in healthcare settings, offering automated record storage of up to 22,000 sterilization cycles with optional printout functionality. The device is classified as Class II (21 CFR 880.2800) under FDA regulations and holds a 510(k) clearance (K170039) for substantial equivalence to prior-generation indicators. Sterility is maintained through manufacturer-controlled packaging, and compatibility is limited to Sterrad sterilization systems.
Frequently asked questions
What is the Sterrad Velocity Biological Indicator and Reader used for in a healthcare setting?
The Sterrad Velocity Biological Indicator and Reader is designed to validate the effectiveness of hydrogen peroxide-based sterilization cycles in Sterrad systems. It combines a biological indicator (BI) with a process challenge device (PCD) to provide real-time verification that microbial contamination is eliminated during sterilization, ensuring the sterility of medical instruments and devices processed in these systems.
Is the Sterrad Velocity Biological Indicator and Reader reusable or intended for single-use?
The Sterrad Velocity Biological Indicator and Reader is explicitly designed for single-use applications in healthcare settings. This ensures sterility and reliability for each sterilization cycle without carryover risks from reuse.
How does the Sterrad Velocity Biological Indicator and Reader store sterilization records?
The system includes a dedicated reader that automatically stores records for up to 22,000 sterilization cycles. Optional printout functionality is also available, allowing healthcare facilities to generate physical copies of sterilization logs as needed.
What type of sterilization systems is the Sterrad Velocity Biological Indicator and Reader compatible with?
The Sterrad Velocity Biological Indicator and Reader is designed exclusively for use with Sterrad sterilization systems that utilize hydrogen peroxide-based sterilization processes. It is not compatible with other sterilization technologies or systems.
How is sterility maintained for the Sterrad Velocity Biological Indicator and Reader?
Sterility is maintained through manufacturer-controlled packaging, ensuring the Biological Indicator/Process Challenge Device (BI/PCD) remains uncontaminated until use. This packaging is designed to be opened only immediately before use in a sterilization cycle.
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: STERRAD VELOCITY™ Biological Indicator System | ASP, STERRAD VELOCITY™ Biological Indicator System - ASP, Biological indicator reader - STERRAD VELOCITY™ - ASP - Advanced ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K170039 | Class II | Active |
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Manufacturer
- Manufacturer
- Advanced Sterilization Products (Asp)
Sources (1)
- FDA 510(k) K170039 24 fields · synced Sep 20, 2026