MEC
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Disinfector, Medical Devices
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.6992
- Medical specialty
- General Hospital
- Adverse events (MAUDE)
- 2021: 93 · 2022: 85 · 2023: 79 · 2024: 78 · 2025: 77 · 2026: 55
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| OLYMPIC PASTEURMATIC, MODELS 3000 AND 3500 (K081094) | Olympic Medical Corp. | 2008-06-20 |
| DECONTAMINATING MACHINES, LS-850, LS-76, DW/T-216, T-21 (K911120) | Hamo USA, Inc. | 1994-02-03 |
Track MEC automatically
Every clearance here is in the API, with alerts when new ones post.