SoClean, Inc
SoClean, Inc appears in FDA public data with 2 recalls, 2 510(k) clearances, 2 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0695-2024, Class II) was initiated on November 15, 2023. Its most recent 510(k) clearance was granted on October 10, 2025.
Summary
- Total Recalls
- 2
- 510(k) Clearances
- 2
- Inspections
- 2
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-0695-2024 | Class II | SoClean 2, REF SC1200, Supplemental Hose and Mask Maintenance System. | November 15, 2023 |
| Z-0694-2024 | Class II | SoClean 3, REF SC1400, Automated Supplemental Sleep Equipment Maintenance System | November 15, 2023 |