Lexa MINI (RIS-303, RIS-305)

FDA 510(k) K233504 · W&H Sterilization S.R.L.

Substantially Equivalent

510(k) numberK233504

Submission

Device name
Lexa MINI (RIS-303, RIS-305)
Applicant
W&H Sterilization S.R.L.
Brusaporto, IT
Received
October 31, 2023
Decision date
February 8, 2024
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
FLE – Sterilizer, Steam
Device class
Class II (moderate risk)
Regulation
21 CFR 880.6880
Specialty
General Hospital

Other 510(k)s with product code FLE

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K261055AMSCO 700 Steam SterilizerFLE · Traditional STERIS Corporation06/24/2026SE
K260254Enbio PROFLE · Traditional Enbio Group AG02/26/2026SE
K252307Getinge GSS67N Series Steam SterilizerFLE · Traditional Maquet GmbH (A Getinge Group Company)01/22/2026SE
K250168Life Ultra 25L Tabletop Mono Chamber Steam SterilizerFLE · Traditional Lucas Lifecare12/30/2025SE
K250164Cassette Autoclave (ACA5)FLE · Traditional Guangzhou Ajax Medical Equipment Co., Ltd.08/14/2025SE
K243994Steam Sterilizer (2545D)FLE · Traditional Ningbo Ican Machines Co., Ltd.06/06/2025SE
K243801FRONT-LINE Field Sterilizer (FL135)FLE · Special Fort Defiance Industries, LLC03/07/2025SE
K233026Midmark Smart M9® Sterilizer, Midmark Smart M11® SterilizerFLE · Traditional Midmark Corporation04/04/2024SE
K233132PRIMUS Healthcare Sterilizer (Model PSS11-HA & PSS11-HB)FLE · Abbreviated Primus Sterilizer Company, LLC12/19/2023SE
K232658T-Top 10 & T-Top T-Top 11FLE · Traditional Tuttnauer U.S.A Co, Ltd.11/27/2023SE

More from Tuttnauer U.S.A Co, Ltd.

510(k)DeviceDecision
K223858Lexa MINI (RIS-303, RIS-305)FLE · Traditional 05/05/2023SE
K213758Lexa PLUS RIS-311FLE · Traditional 08/19/2022SE
K172825MN-111FLE · Traditional 05/30/2018SE

Questions and answers

When was Lexa MINI (RIS-303, RIS-305) cleared by the FDA?

Lexa MINI (RIS-303, RIS-305) (K233504) received a 510(k) decision of Substantially Equivalent on February 8, 2024, 100 days after the submission was received.

What is the product code of K233504?

The FDA product code is FLE – Sterilizer, Steam, a Class II (moderate risk) device regulated under 21 CFR 880.6880.