Lexa Mini (RIS-303, RIS-305)
by W&H Sterilization S.R.L. EUDAMED510(k)
Active
510(k) K223858
Overview
The Lexa Mini (RIS-303, RIS-305) is a Steam Sterilizer, designed for the sterilisation of medical and surgical instruments using saturated steam under pressure. It operates as a Class II device, adhering to regulatory standards for hospital-grade sterilisation processes.
This device is intended for use in general hospital settings and is supplied as a reusable medical instrument. It complies with FDA 510(k) clearance and MDR requirements, ensuring compliance with both traditional and modern regulatory frameworks. The steriliser is not MRI-safe and requires proper storage and maintenance as specified in its operational manual.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK223858 | Date5 May 2023 | StatusActive |
| European Union | CE/MDR EUDAMED | Number— | Date— | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
- European Union
- United States
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- FLE
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.6880
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Other devices from W&H Sterilization S.R.L.
Questions
What types of medical instruments can the Lexa MINI sterilizer process, and is it suitable for use in all hospital departments?
The Lexa MINI (RIS-303, RIS-305) is a steam sterilizer designed specifically for general hospital settings, as indicated by its advisory committee classification. It is intended for sterilizing medical and surgical instruments using saturated steam under pressure. While it is suitable for most hospital departments, its primary focus is on standardizing sterilization processes for reusable instruments in environments where high-volume, reliable sterilization is required. Always refer to the operational manual for specific instrument compatibility and cycle parameters.
Is the Lexa MINI sterilizer reusable, and if so, what maintenance or care is required to ensure its longevity?
Yes, the Lexa MINI is supplied as a reusable medical instrument. To ensure its longevity and proper function, it requires regular maintenance as outlined in the manufacturer’s operational manual. This includes routine cleaning, periodic inspections, and adherence to the sterilizer’s operational guidelines. Proper storage, as specified in the manual, is also essential to prevent damage and maintain performance.
What regulatory pathways has the Lexa MINI sterilizer followed, and how does this affect its use in clinical settings?
The Lexa MINI has undergone FDA 510(k) clearance and complies with MDR (Medical Device Regulation) requirements, confirming its adherence to both traditional and modern regulatory standards. This ensures that the device meets stringent safety, performance, and quality criteria for use in clinical settings. The clearance and compliance do not alter its intended purpose but provide assurance of its reliability and suitability for hospital-grade sterilization processes.
Are there any specific storage requirements for the Lexa MINI sterilizer to maintain its functionality and sterility?
The Lexa MINI requires proper storage as detailed in its operational manual to maintain its functionality and ensure longevity. While the manual does not specify sterility requirements for storage (as it is a reusable device), it must be kept in a clean, dry environment, protected from physical damage, and away from sources of contamination or extreme temperatures. Always follow the manufacturer’s guidelines to avoid compromising performance.