Chrysalis Intelligence · Sponsors · Soclean, Inc.

Soclean, Inc.

Peterborough, NH, US · 2 510(k) clearances · 2 recalls

Total clearances
2
2024-08-12 → 2025-10-10
Last 12 months
1
Product codes
1
Most recent
2025-10-10
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
QXQ Respiratory Accessory Microbial Reduction Device. Class II General Hospital 2 2025-10-10
Safety

Recalls (2)

Class I (serious)
0
Risk of injury / death
Total recalls
2
Currently ongoing
2
Most recent
2023-11-15
DateSeverityStatusRecall # ProductCodeReason
2023-11-15 Class II Ongoing Z-0695-2024 SoClean 2, REF SC1200, Supplemental Hose and Mask Maintenance System. New User Manual with additional instructions for use and a hose and mask adapter provided by the device manufacturer. This voluntary recall is intended to help …
2023-11-15 Class II Ongoing Z-0694-2024 SoClean 3, REF SC1400, Automated Supplemental Sleep Equipment Maintenance System New User Manual with additional instructions for use and a hose and mask adapter provided by the device manufacturer. This voluntary recall is intended to help …
Filings

All 510(k) clearances (2)

Date K-number Device Code Class Specialty
2025-10-10 K243815 SoClean 3+ QXQ Class II General Hospital
2024-08-12 DEN210037 SoClean 3+ Bacterial Reduction Device QXQ Class II General Hospital