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 880.6860](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/880.6860) → MLR — Sterilizer, Chemical # MLR · Sterilizer, Chemical _General Hospital · 21 CFR 880.6860 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/MLR ## Overview - **Product Code:** MLR - **Device Name:** Sterilizer, Chemical - **Regulation:** [21 CFR 880.6860](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/880.6860) - **Device Class:** 2 - **Review Panel:** [General Hospital](/submissions/HO) - **3rd-party reviewable:** yes ## Identification An ethylene gas sterilizer is a nonportable device intended for use by a health care provider that uses ethylene oxide (ETO) to sterilize medical products. ## Classification Rationale Class II (performance standards). ## Recent Cleared Devices (20 of 47) Showing 20 most recent of 47 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K252843](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/MLR/K252843.md) | STERRAD 100NX Sterilization System with ALLClear Technology (10104) | Advanced Sterilization Products, Inc. | Apr 15, 2026 | SESE | | [K250802](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/MLR/K250802.md) | STERRAD® 100NX Sterilizer with ALLClear™ Technology (10104) | Advanced Sterilization Products, Inc. | Apr 14, 2025 | SESE | | [K231893](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/MLR/K231893.md) | LOWTEM Crystal 120 | Lowtem Co., Ltd. | Sep 18, 2024 | SESE | | [K234082](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/MLR/K234082.md) | STERRAD® 100NX Sterilizer with ALLClear™ Technology and ULTRA GI™ Cycle (10104); APTIMAX™ Instrument Tray for ULTRA GI™ Cycle (011077) | Advanced Sterilization Products | Jul 5, 2024 | SESE | | [K233762](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/MLR/K233762.md) | SteroScope® Sterilization Technology System | Ideate Medical, Inc. | Jun 27, 2024 | SESE | | [K233065](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/MLR/K233065.md) | V-PRO maX 2 Low Temperature Sterilization System | Steris | Oct 20, 2023 | SESE | | [K223476](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/MLR/K223476.md) | V-PRO maX 2 Low Temperature Sterilization System | STERIS Corporation | Aug 7, 2023 | SESE | | [K231169](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/MLR/K231169.md) | STERLINK plus Sterilizer with STERLOAD Cassette, Tyvek Roll with CI for STERLINK Sterilizer, Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40) | Plasmapp Co,., Ltd. | May 25, 2023 | SESE | | [K223015](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/MLR/K223015.md) | STERLINK™ FPS-15s Plus sterilizer with STERPACK™ plus cassette | Plasmapp Co,., Ltd. | May 9, 2023 | SESE | | [K220345](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/MLR/K220345.md) | STERLINK mini Sterilizer with STERLOAD mini Cassette, Tyvek Roll with CI for STERLINK Sterilizer, Sterilization Process Indicator for STERLINK Sterilizer; Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-Bio), Terragene Chemdye (CD42), Terragene Cintape (CT40) | Plasmapp Co,., Ltd. | Apr 14, 2023 | SESE | | [K222093](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/MLR/K222093.md) | V-PRO maX 2 Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System | Steris | Sep 9, 2022 | SESE | | [K220404](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/MLR/K220404.md) | STERRAD NX with ALLClear Technology | Advanced Sterilization Products, Inc. | May 16, 2022 | SESE | | [K212200](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/MLR/K212200.md) | STERLINKTM FPS-15s Plus Sterilizer with STERLOADTM Cassette | Plasmapp Co,., Ltd. | Oct 22, 2021 | SESE | | [K212174](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/MLR/K212174.md) | STERRAD 100NX Sterilizer with ALLClear Technology | Advanced Sterilization Products, Inc. | Oct 9, 2021 | SESE | | [K190005](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/MLR/K190005.md) | Sterilucent HC 80TT Hydrogen Peroxide Sterilizer | Sterilucent, Inc. | Sep 13, 2019 | SESE | | [K190917](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/MLR/K190917.md) | V-PRO 60 a Low Tempurature Strilization Systems, V-PRO s2 Low Temperature Sterilization Systems | STERIS Corporation | May 9, 2019 | SESE | | [K190103](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/MLR/K190103.md) | V-PRO maX 2 Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System, V-PRO 1 Plus Low Temperature Sterilization System, V-PRO 1 Low Temperature Sterilization System | STERIS Corporation | Apr 5, 2019 | SESE | | [K182568](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/MLR/K182568.md) | V-PRO s2 Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization System | STERIS Corporation | Jan 3, 2019 | SESE | | [K172754](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/MLR/K172754.md) | V-PRO maX 2 Low Temperature Sterilization System | STERIS Corporation | Feb 9, 2018 | SESE | | [K172319](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/MLR/K172319.md) | AMSCO V-PRO 1 Low Temperature Sterilization System, AMSCO V-PRO 1 Plus Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization System | STERIS Corporation | Jan 18, 2018 | SESE | ## Top Applicants - STERIS Corporation — 17 clearances - Advanced Sterilization Products — 13 clearances - Advanced Sterilization Products, Inc. — 4 clearances - Plasmapp Co,., Ltd. — 4 clearances - Sterilucent, Inc. — 2 clearances --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/MLR](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/MLR) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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