# K213758: Lexa PLUS RIS-311

- Pathway: 510(k) (Traditional)
- Applicant: W&H Sterilization S.R.L.
- Decided: Aug 19, 2022 after 262 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
RIS-311 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 RIS-311 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 table: Program: Wrapped Type of Load and Load Weight: Pouched Instruments and Dental Handpieces on trays 14 Ibs (6.3 kg) (trays excluded). Instruments and dental handpieces in wrapped cassettes or in trays and wrapped cassettes 16.5 Ibs (7.5 kg) (trays and cassettes included). Pouched Textile load on trays 4.41bs (2.0 kg) (trays excluded). Sterilization Temperature: 270°F (132°C) Sterilization Time: 4 minutes Drying Time (Recommended): 22 minutes Program: Low Temperature Type of Load and Load Weight: Pouched Instruments (solid instruments) on trays 14bs (6.3kg) (trays excluded) Solid instruments in wrapped cassettes or in trays and wrapped cassettes 16.51bs (7.5 kg) (trays and cassettes included). Pouched Textile load on trays 4.4 Ibs (2.0 kg) (trays excluded) Sterilization Temperature: 250°F (121°C) Sterilization Time: 30 minutes Drying Time (Recommended): 28 minutes Program: Unwrapped Type of Load and Load Weight: Instruments and dental handpieces, up to 18 bs (8.1kg) Sterilization Temperature: 270°F (132°C) Sterilization Time: 3.30 minutes Drying Time (Recommended): 4 minutes

Source page: https://510kreport.com/device/K213758
Methodology: https://510kreport.com/methodology