STERRAD NX Sterilizer, STERRAD 100NX Sterilizer
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K151725 FDA 510(k)
- FDA Product Code
- MLR FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 880.6860 FDA 510(k)
- Regulation Number
- 880.6860 FDA 510(k)
- Advisory Committee
- General Hospital FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The STERRAD NX Sterilizer and STERRAD 100NX Sterilizer are low-temperature chemical sterilizers designed for hospital use. These devices employ plasma technology to achieve sterilization through hydrogen peroxide vapor, eliminating microbial contaminants on reusable medical instruments and devices. They are classified as Class II devices under FDA regulations and are intended for use in general hospital settings. The sterilizers are engineered to process a variety of medical instruments, including flexible endoscopes, while maintaining material integrity and reducing thermal damage.
The STERRAD NX and STERRAD 100NX Sterilizers are supplied as standalone systems for installation in hospital sterilization rooms. They operate using a low-temperature process, typically within cycles of 28 to 38 minutes, and are reusable devices intended for repeated use in controlled environments. The systems are not MRI-compatible and require proper storage in a clean, dry area away from direct sunlight. Authorized for use in the United States under FDA 510(k) clearance (K151725), these sterilizers adhere to regulatory standards for chemical sterilization in healthcare facilities.
Frequently asked questions
What types of medical instruments can the STERRAD NX Sterilizer process?
The STERRAD NX Sterilizer is designed to process a wide range of reusable medical instruments, with a specific focus on flexible endoscopes. Its low-temperature plasma sterilization process ensures microbial elimination while preserving material integrity and minimizing thermal damage, making it suitable for delicate or heat-sensitive instruments commonly used in general hospital settings.
How long does a typical sterilization cycle take with the STERRAD NX Sterilizer?
Each sterilization cycle for the STERRAD NX Sterilizer typically lasts between 28 to 38 minutes. This low-temperature process leverages hydrogen peroxide vapor and plasma technology to achieve effective sterilization without the prolonged exposure times associated with traditional high-temperature methods.
Is the STERRAD NX Sterilizer reusable, or is it a single-use device?
The STERRAD NX Sterilizer is a reusable device intended for repeated use in controlled hospital environments. It is supplied as a standalone system and must be maintained according to manufacturer guidelines to ensure consistent performance and compliance with sterilization protocols.
What storage conditions are required for the STERRAD NX Sterilizer?
The STERRAD NX Sterilizer should be stored in a clean, dry area away from direct sunlight. Proper storage conditions help maintain the device’s functionality and ensure longevity, as it is designed for long-term use in hospital sterilization rooms.
Can the STERRAD NX Sterilizer be used in an MRI environment?
No, the STERRAD NX Sterilizer is not MRI-compatible. It is specifically engineered for installation in dedicated hospital sterilization rooms and should not be placed in areas where MRI equipment is operated.
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™ 100NX System with ALLClear™ Technology - ASP, Sterilisator STERRAD™ 100NX mit ALLClear™-Technologie - ASP, STERRAD NX™ System with ALLClear™ Technology - ASP, Medical sterilizer - STERRAD™ 100NX - ASP - Advanced Sterilization ..., 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 | K151725 | Class II | Active |
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Manufacturer
- Manufacturer
- Advanced Sterilization Products
Sources (1)
- FDA 510(k) K151725 24 fields · synced Oct 1, 2026