MLR — Sterilizer, Chemical Class II
FDA product code MLR covers "Sterilizer, Chemical", a Class II medical device regulated under 21 CFR 880.6860. 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
- MLR
- Device Class
- Class II
- Regulation Number
- 880.6860
- Submission Type
- Review Panel
- HO
- Medical Specialty
- General Hospital
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K252843 | advanced sterilization products | STERRAD 100NX Sterilization System with ALLClear Technology (10104) | April 15, 2026 |
| K250802 | advanced sterilization products | STERRAD® 100NX Sterilizer with ALLClear Technology (10104) | April 14, 2025 |
| K231893 | lowtem co | LOWTEM Crystal 120 | September 18, 2024 |
| K234082 | advanced sterilization products | STERRAD® 100NX Sterilizer with ALLClear Technology and ULTRA GI Cycle (10104); | July 5, 2024 |
| K233762 | ideate medical | SteroScope® Sterilization Technology System | June 27, 2024 |
| K233065 | steris | V-PRO maX 2 Low Temperature Sterilization System | October 20, 2023 |
| K223476 | steris corporation | V-PRO maX 2 Low Temperature Sterilization System | August 7, 2023 |
| K231169 | plasmapp co | STERLINK plus Sterilizer with STERLOAD Cassette, Tyvek Roll with CI for STERLINK | May 25, 2023 |
| K223015 | plasmapp co | STERLINK FPS-15s Plus sterilizer with STERPACK plus cassette | May 9, 2023 |
| K220345 | plasmapp co | STERLINK mini Sterilizer with STERLOAD mini Cassette, Tyvek Roll with CI for STE | April 14, 2023 |
| K222093 | steris | V-PRO maX 2 Low Temperature Sterilization System, V-PRO maX Low Temperature Ster | September 9, 2022 |
| K220404 | advanced sterilization products | STERRAD NX with ALLClear Technology | May 16, 2022 |
| K212200 | plasmapp co | STERLINKTM FPS-15s Plus Sterilizer with STERLOADTM Cassette | October 22, 2021 |
| K212174 | advanced sterilization products | STERRAD 100NX Sterilizer with ALLClear Technology | October 9, 2021 |
| K190005 | sterilucent | Sterilucent HC 80TT Hydrogen Peroxide Sterilizer | September 13, 2019 |
| K190917 | steris corporation | V-PRO 60 a Low Tempurature Strilization Systems, V-PRO s2 Low Temperature Steril | May 9, 2019 |
| K190103 | steris corporation | V-PRO maX 2 Low Temperature Sterilization System, V-PRO maX Low Temperature Ster | April 5, 2019 |
| K182568 | steris corporation | V-PRO s2 Low Temperature Sterilization System, V-PRO 60 Low Temperature Steriliz | January 3, 2019 |
| K172754 | steris corporation | V-PRO maX 2 Low Temperature Sterilization System | February 9, 2018 |
| K172319 | steris corporation | AMSCO V-PRO 1 Low Temperature Sterilization System, AMSCO V-PRO 1 Plus Low Tempe | January 18, 2018 |