510(k) · Cleared
ClearedLexa PLUS RIS-311
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
W&H Sterilization S.R.L. · FLE Sterilizer, Steam
Cleared on Aug 19, 2022 after a 262-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Aug 19, 2022
- Review
- 262 days
- Class
- Class II
- Product code
- FLE
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in FLE? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new FLE device
- #1 K250168 Life Ultra 25L Tabletop Mono Chamber Steam…score 12.7 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All FLE devicesFLE Sterilizer, Steam: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · FLE
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FLE
184in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FLE
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FLE
71in 2025
MAUDE reports naming product code FLE, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 5 | 67 | 1 | 19 |
| 2008 | 1 | — | 1 | 21 |
| 2009 | 8 | 109 | 0 | 19 |
| 2010 | 2 | — | 0 | 20 |
| 2011 | 5 | 141 | 1 | 63 |
| 2012 | 5 | 111 | 1 | 69 |
| 2013 | 5 | 241 | 2 | 112 |
| 2014 | 2 | — | 0 | 113 |
| 2015 | 3 | 302 | 1 | 68 |
| 2016 | 1 | — | 0 | 76 |
| 2017 | 3 | 233 | 0 | 63 |
| 2018 | 8 | 146 | 1 | 90 |
| 2019 | 5 | 192 | 2 | 91 |
| 2020 | 2 | — | 0 | 87 |
| 2021 | 5 | 147 | 1 | 81 |
| 2022 | 10 | 133 | 0 | 70 |
| 2023 | 7 | 88 | 0 | 66 |
| 2024 | 2 | — | 0 | 64 |
| 2025 | 4 | 184 | 0 | 71 |
| 2026 | 3 | 85 | 1 | — |
What is it indicated for?
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…
Read the full statement (250 words)
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
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K213758 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213758: Lexa PLUS RIS-311.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K213758
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026