MLR
- Product code
- MLR
- Device name
- Sterilizer, Chemical
- Device class
- Class 2
- 21 CFR
- 21 CFR 880.6860
- Medical specialty
- General Hospital
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 6
- Summaries archived here
- 4 (direct download)
- 510(k) clearances (all years, FDA)
- 47 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (6)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K252843 | 2026-04-15 | Advanced Sterilization Products, Inc. | STERRAD 100NX Sterilization System with ALLClear Tec… | FDA |
| K250802 | 2025-04-14 | Advanced Sterilization Products, Inc. | STERRAD® 100NX Sterilizer with ALLClear Technology … | |
| K231893 | 2024-09-18 | Lowtem Co., Ltd. | LOWTEM Crystal 120 | FDA |
| K234082 | 2024-07-05 | Advanced Sterilization Products | STERRAD® 100NX Sterilizer with ALLClear Technology … | |
| K233762 | 2024-06-27 | Ideate Medical, Inc. | SteroScope® Sterilization Technology System | |
| K233065 | 2023-10-20 | Steris | V-PRO maX 2 Low Temperature Sterilization System |
Official FDA classification page: MLR
Classification and pathway per current FDA publications. Data from openFDA (CC0).