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SoClean, Inc

FDA Regulatory Profile

Summary

Total Recalls
2
510(k) Clearances
2
Inspections
2
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0694-2024Class IISoClean 3, REF SC1400, Automated Supplemental Sleep Equipment Maintenance SystemNovember 15, 2023
Z-0695-2024Class IISoClean 2, REF SC1200, Supplemental Hose and Mask Maintenance System.November 15, 2023

Recent 510(k) Clearances

K-NumberDeviceDate
K243815SoClean 3+October 10, 2025
DEN210037SoClean 3+ Bacterial Reduction DeviceAugust 12, 2024