MLRClass II
Sterilizer, Chemical
21 CFR 880.6860 / General Hospital
MLR is the FDA product code for Sterilizer, Chemical, a class II device type, regulated under 21 CFR 880.6860. As of , FDA records hold 47 510(k) clearances under this code, the most recent dated , and 46 recalls.
Classification record
- Product code
- MLR
- Device name
- Sterilizer, Chemical
- Regulation
- 21 CFR 880.6860
- Device class
- Class II
- Review panel
- General Hospital
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- Yes
- Ingested clearances
- 47
- Ingested recalls
- 46
Clearances, product code MLR
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1994 | 1 |
| 1995 | 1 |
| 1999 | 1 |
| 2000 | 1 |
| 2003 | 1 |
| 2005 | 1 |
| 2007 | 2 |
| 2009 | 1 |
| 2011 | 6 |
| 2012 | 2 |
| 2013 | 1 |
| 2014 | 2 |
| 2015 | 1 |
| 2016 | 4 |
| 2017 | 2 |
| 2018 | 2 |
| 2019 | 4 |
| 2021 | 2 |
| 2022 | 2 |
| 2023 | 5 |
| 2024 | 3 |
| 2025 | 1 |
| 2026 | 1 |
Applicants with the most clearances
Product code MLR| Applicant | Clearances |
|---|---|
| STERIS Corporation | 20 |
| Advanced Sterilization Products | 17 |
| Plasmapp Co., Ltd. | 4 |
| Sterilucent, Inc. | 2 |
| Ideate Medical | 1 |
| Lowtem Co., Ltd. | 1 |
| Mdt Biologic Co. | 1 |
| Mdt Corp., Inc. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.