MED · Sterilant, Medical Devices
General Hospital · 21 CFR 880.6885 · Class 2
Overview
| Product Code | MED |
|---|---|
| Device Name | Sterilant, Medical Devices |
| Regulation | 21 CFR 880.6885 |
| Device Class | Class 2 |
| Review Panel | General Hospital |
| 3rd-Party Reviewable | Yes |
Identification
A liquid chemical sterilant/high level disinfectant is a germicide that is intended for use as the terminal step in processing critical and semicritical medical devices prior to patient use. Critical devices make contact with normally sterile tissue or body spaces during use. Semicritical devices make contact during use with mucous membranes or nonintact skin.
Classification Rationale
Class II (special controls). Guidance on the Content and Format of Premarket Notification (510(k)) Submissions for Liquid Chemical Sterilants/High Level Disinfectants, and user information and training.
Special Controls
*Classification.* Class II (special controls). Guidance on the Content and Format of Premarket Notification (510(k)) Submissions for Liquid Chemical Sterilants/High Level Disinfectants, and user information and training.
Recent Cleared Devices (20 of 64)
Showing 20 most recent of 64 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K251666 | SYSTEM 1E Liquid Chemical Sterilant Processing System, Model P6700; SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900 | STERIS Corporation | Apr 8, 2026 | SESE |
| K232914 | SYSTEM 1E Liquid Chemical Sterilant Processing System (P6500); SYSTEM 1 endo Liquid Chemical Sterilant Processing System (P6800); SYSTEM 1 endo Liquid Chemical Sterilant Processing System (P6900) | STERIS Corporation | Oct 3, 2023 | SESE |
| K230582 | SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900 | STERIS Corporation | Mar 28, 2023 | SESE |
| K222615 | SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900, S40 Sterilant Concentrate | STERIS Corporation | Sep 28, 2022 | SESE |
| K211607 | SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900, S40 Sterilant Concentrate | STERIS Corporation | Sep 7, 2021 | SESE |
| K210737 | SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900, S40 Sterilant Concentrate | STERIS Corporation | May 12, 2021 | SESE |
| K192929 | SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900 | STERIS Corporation | Dec 10, 2019 | SESE |
| K191343 | SYSTEM 1 endo Liquid Chemical Sterilant Processing System,Model P6900 | STERIS Corporation | Sep 5, 2019 | SESE |
| K190104 | SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 Endo Liquid Chemical Sterilant Processing System | Steris Corporations | Mar 22, 2019 | SESE |
| K182827 | SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model 6900 | STERIS Corporation | Jan 31, 2019 | SESE |
| K180342 | SYSTEM 1E Liquid Chemical Sterilant Processing System | Steris Corporations | Apr 4, 2018 | SESE |
| K173256 | System 1 endo Liquid Chemical Sterilant Processing System | STERIS Corporation | Mar 2, 2018 | SESE |
| K170956 | SYSTEM 1E Liquid Chemical Sterilant Processing System | STERIS Corporation | Sep 22, 2017 | SESE |
| K161683 | SYSTEM 1E Liquid Chemical Sterilant Processing System | STERIS Corporation | Aug 5, 2016 | SESE |
| K140703 | OPA 30 SOLUTION | Ciden Technologies, LLC | Aug 19, 2014 | SESE |
| K131078 | SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM | STERIS Corporation | Jul 5, 2013 | SESE |
| K120306 | RAPICIDE OPA-28 | Minntech Corp. | Sep 27, 2012 | SESE |
| K113520 | SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM | STERIS Corporation | Feb 21, 2012 | SESE |
| K113015 | ALDAHOL V HIGH LEVEL DISINFECTANT | Microchem Laboratories, Inc. | Jan 30, 2012 | SESE |
| K102462 | SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM | STERIS Corporation | Sep 21, 2010 | SESE |
Top Applicants
- STERIS Corporation — 19 clearances
- Advanced Sterilization Products — 5 clearances
- Cottrell, Ltd. — 3 clearances
- Metrex Research Corp. — 3 clearances
- Best Sanitizers, Inc. — 2 clearances
