MED — Sterilant, Medical Devices Class II
FDA product code MED covers "Sterilant, Medical Devices", a Class II medical device regulated under 21 CFR 880.6885. Submissions are reviewed by the General Hospital panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- MED
- Device Class
- Class II
- Regulation Number
- 880.6885
- Submission Type
- Review Panel
- HO
- Medical Specialty
- General Hospital
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K251666 | steris corporation | SYSTEM 1E Liquid Chemical Sterilant Processing System, Model P6700; SYSTEM 1 end | April 8, 2026 |
| K232914 | steris corporation | SYSTEM 1E Liquid Chemical Sterilant Processing System (P6500); SYSTEM 1 endo Liq | October 3, 2023 |
| K230582 | steris corporation | SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900 | March 28, 2023 |
| K222615 | steris corporation | SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chem | September 28, 2022 |
| K211607 | steris corporation | SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chem | September 7, 2021 |
| K210737 | steris corporation | SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chem | May 12, 2021 |
| K192929 | steris corporation | SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chem | December 10, 2019 |
| K191343 | steris corporation | SYSTEM 1 endo Liquid Chemical Sterilant Processing System,Model P6900 | September 5, 2019 |
| K190104 | steris corporations | SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 Endo Liquid Chem | March 22, 2019 |
| K182827 | steris corporation | SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model 6900 | January 31, 2019 |
| K180342 | steris corporations | SYSTEM 1E Liquid Chemical Sterilant Processing System | April 4, 2018 |
| K173256 | steris corporation | System 1 endo Liquid Chemical Sterilant Processing System | March 2, 2018 |
| K170956 | steris corporation | SYSTEM 1E Liquid Chemical Sterilant Processing System | September 22, 2017 |
| K161683 | steris corporation | SYSTEM 1E Liquid Chemical Sterilant Processing System | August 5, 2016 |
| K140703 | ciden technologies | OPA 30 SOLUTION | August 19, 2014 |
| K131078 | steris corporation | SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM | July 5, 2013 |
| K120306 | minntech | RAPICIDE OPA-28 | September 27, 2012 |
| K113520 | steris corporation | SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM | February 21, 2012 |
| K113015 | microchem laboratories | ALDAHOL V HIGH LEVEL DISINFECTANT | January 30, 2012 |
| K102462 | steris corporation | SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM | September 21, 2010 |