Browse hierarchy: [General Hospital (HO)](/submissions/HO) → [Subpart G — General Hospital and Personal Use Miscellaneous Devices](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices) → [21 CFR 880.6880](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/880.6880) → FLE — Sterilizer, Steam # FLE · Sterilizer, Steam _General Hospital · 21 CFR 880.6880 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FLE ## Overview - **Product Code:** FLE - **Device Name:** Sterilizer, Steam - **Regulation:** [21 CFR 880.6880](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/880.6880) - **Device Class:** 2 - **Review Panel:** [General Hospital](/submissions/HO) - **3rd-party reviewable:** yes ## Identification A steam sterilizer (autoclave) is a device that is intended for use by a health care provider to sterilize medical products by means of pressurized steam. ## Classification Rationale Class II (performance standards). ## Recent Cleared Devices (20 of 184) Showing 20 most recent of 184 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K260254](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FLE/K260254.md) | Enbio PRO | Enbio Group AG | Feb 26, 2026 | SESE | | [K252307](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FLE/K252307.md) | Getinge GSS67N Series Steam Sterilizer | Maquet GmbH (A Getinge Group Company) | Jan 22, 2026 | SESE | | [K250168](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FLE/K250168.md) | Life Ultra 25L Tabletop Mono Chamber Steam Sterilizer | Lucas Lifecare | Dec 30, 2025 | SESE | | [K250164](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FLE/K250164.md) | Cassette Autoclave (ACA5) | Guangzhou Ajax Medical Equipment Co., Ltd. | Aug 14, 2025 | SESE | | [K243994](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FLE/K243994.md) | Steam Sterilizer (2545D) | Ningbo Ican Machines Co., Ltd. | Jun 6, 2025 | SESE | | [K243801](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FLE/K243801.md) | FRONT-LINE Field Sterilizer (FL135) | Fort Defiance Industries, LLC | Mar 7, 2025 | SESE | | [K233026](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FLE/K233026.md) | Midmark Smart M9® Sterilizer, Midmark Smart M11® Sterilizer | Midmark Corporation | Apr 4, 2024 | SESE | | [K233504](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FLE/K233504.md) | Lexa MINI (RIS-303, RIS-305) | W&H Sterilization S.R.L. | Feb 8, 2024 | SESE | | [K233132](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FLE/K233132.md) | PRIMUS Healthcare Sterilizer (Model PSS11-HA & PSS11-HB) | Primus Sterilizer Company, LLC | Dec 19, 2023 | SESE | | [K232658](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FLE/K232658.md) | T-Top 10 & T-Top T-Top 11 | Tuttnauer U.S.A Co, Ltd. | Nov 27, 2023 | SESE | | [K232485](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FLE/K232485.md) | AMSCO 600 Steam Sterilizer | Steris | Sep 13, 2023 | SESE | | [K231489](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FLE/K231489.md) | Sturdy Autoclave Super Microm | Sturdy Industrial Co., Ltd. | Jun 21, 2023 | SESE | | [K223858](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FLE/K223858.md) | Lexa MINI (RIS-303, RIS-305) | W&H Sterilization S.R.L. | May 5, 2023 | SESE | | [K221474](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FLE/K221474.md) | PRIMUS Healthcare Sterilizer (Model PSS11-HC) | Primus Sterilizer Company, LLC | Feb 10, 2023 | SESE | | [K213545](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FLE/K213545.md) | Steelco VS Series Steam Sterilizers, models 262839, 262851, 262869 | Steelco S.P.A. | Feb 2, 2023 | SESE | | [K222608](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FLE/K222608.md) | Tuttnauer Pre-vacuum Steam Sterilizer models 3870HSG and 3870HSG-WS | Tuttnauer , Ltd. | Dec 16, 2022 | SESE | | [K220102](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FLE/K220102.md) | MOST-T Autoclave | Shinva Medical Instrument Co., Ltd. | Oct 12, 2022 | SESE | | [K221227](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FLE/K221227.md) | Tuttnauer Horizontal autoclave series model: 4472, 5596, 6690, 66120 | Tuttnauer , Ltd. | Sep 20, 2022 | SESE | | [K213758](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FLE/K213758.md) | Lexa PLUS RIS-311 | W&H Sterilization S.R.L. | Aug 19, 2022 | SESE | | [K220736](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FLE/K220736.md) | Consolidated HC Steam Sterilizer | Consolidated Machine Corp. | Aug 1, 2022 | SESE | ## Top Applicants - STERIS Corporation — 21 clearances - Tuttnauer U.S.A Co, Ltd. — 8 clearances - Midmark Corp. — 7 clearances - Scican , Ltd. — 7 clearances - Getinge/Castle, Inc. — 6 clearances --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FLE](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FLE) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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