MED
- Product code
- MED
- Device name
- Sterilant, Medical Devices
- Device class
- Class 2
- 21 CFR
- 21 CFR 880.6885
- Medical specialty
- General Hospital
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 64
510(k) clearances, last 3 years (2)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K251666 | 2026-04-08 | STERIS Corporation | SYSTEM 1E Liquid Chemical Sterilant Processing Syste | |
| K232914 | 2023-10-03 | STERIS Corporation | SYSTEM 1E Liquid Chemical Sterilant Processing Syste |
Official FDA classification page: MED
Classification and pathway per current FDA publications. Data from openFDA (CC0).