MLR · Sterilizer, Chemical
General Hospital · 21 CFR 880.6860 · Class 2
Overview
| Product Code | MLR |
|---|---|
| Device Name | Sterilizer, Chemical |
| Regulation | 21 CFR 880.6860 |
| Device Class | Class 2 |
| Review Panel | General Hospital |
| 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 | STERRAD 100NX Sterilization System with ALLClear Technology (10104) | Advanced Sterilization Products, Inc. | Apr 15, 2026 | SESE |
| K250802 | STERRAD® 100NX Sterilizer with ALLClear Technology (10104) | Advanced Sterilization Products, Inc. | Apr 14, 2025 | SESE |
| K231893 | LOWTEM Crystal 120 | Lowtem Co., Ltd. | Sep 18, 2024 | SESE |
| K234082 | 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 | SteroScope® Sterilization Technology System | Ideate Medical, Inc. | Jun 27, 2024 | SESE |
| K233065 | V-PRO maX 2 Low Temperature Sterilization System | Steris | Oct 20, 2023 | SESE |
| K223476 | V-PRO maX 2 Low Temperature Sterilization System | STERIS Corporation | Aug 7, 2023 | SESE |
| K231169 | 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 | STERLINK FPS-15s Plus sterilizer with STERPACK plus cassette | Plasmapp Co,., Ltd. | May 9, 2023 | SESE |
| K220345 | 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 | V-PRO maX 2 Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System | Steris | Sep 9, 2022 | SESE |
| K220404 | STERRAD NX with ALLClear Technology | Advanced Sterilization Products, Inc. | May 16, 2022 | SESE |
| K212200 | STERLINKTM FPS-15s Plus Sterilizer with STERLOADTM Cassette | Plasmapp Co,., Ltd. | Oct 22, 2021 | SESE |
| K212174 | STERRAD 100NX Sterilizer with ALLClear Technology | Advanced Sterilization Products, Inc. | Oct 9, 2021 | SESE |
| K190005 | Sterilucent HC 80TT Hydrogen Peroxide Sterilizer | Sterilucent, Inc. | Sep 13, 2019 | SESE |
| K190917 | V-PRO 60 a Low Tempurature Strilization Systems, V-PRO s2 Low Temperature Sterilization Systems | STERIS Corporation | May 9, 2019 | SESE |
| K190103 | 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 | V-PRO s2 Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization System | STERIS Corporation | Jan 3, 2019 | SESE |
| K172754 | V-PRO maX 2 Low Temperature Sterilization System | STERIS Corporation | Feb 9, 2018 | SESE |
| K172319 | 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
