# K233504: Lexa MINI (RIS-303, RIS-305)

- Pathway: 510(k) (Traditional)
- Applicant: W&H Sterilization S.R.L.
- Decided: Feb 8, 2024 after 100 days
- Product code: FLE (Sterilizer, Steam)
- Device class: 2
- Regulation: 21 CFR 880.6880
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Lexa MINI is a dynamic-air-removal (pre-vacuum) table-top steam sterilizer intended for use by a healthcare provider to sterilize medical products by means of pressurized steam. It is suitable for the sterilization of medical and dental instruments that are validated to be sterilized by steam. The Lexa MINI has not been designed to sterilize liquid loads, biomedical waste or materials not compatible with steam sterilization. The processing of such loads may result in incomplete sterilization and/or damage to the autoclave. Key program features, including sterilization time, temperature and recommended load type are listed in the following: - Wrapped & Porous (270°F/132°C): 4' sterilization time; 10' drying time (recom.); for all types of load; wrapped items (Lexa MINI RIS-303: 2.2 lbs / Lexa MINI RIS-305: 3.3 lbs); wrapped Porous/Textile load (0.22 lbs) - Wrapped (270°F/132°C): 4' sterilization time; 10' drying time (recom.) for all types of load; except porous/textile load; wrapped items (Lexa MINI RIS-303: 2.2 lbs / Lexa MINI RIS-305: 3.3 lbs) - Low Temperature (250°C/121°C): 30' sterilization time, 10' drying time (recom.); for all types of load; wrapped items (Lexa MINI RIS-303: 2.2 lbs / Lexa MINI RIS-305: 3.3 lbs); wrapped Porous/Textile load (0.22 lbs) - Unwrapped (270°F/132°C): 4' sterilization time, 1' drying time (recom.) for all types of load; except porous/textile load; unwrapped items (Lexa MINI RIS-303: 2.2 lbs / Lexa MINI RIS-305: 3.3 lbs)

Source page: https://510kreport.com/device/K233504
Methodology: https://510kreport.com/methodology