K243815 is an FDA 510(k) clearance for the SoClean 3+. This device is classified as a Respiratory Accessory Microbial Reduction Device. (Class II - Special Controls, product code QXQ).
Submitted by Soclean, Inc. (Peterborough, US). The FDA issued a Cleared decision on October 10, 2025, 303 days after receiving the submission on December 11, 2024.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6993. A Respiratory Accessory Microbial Reduction Device Is A Home-use Device Intended To Be Used As An Adjunct For Microbial Reduction Of Compatible Respiratory Accessories,such As Hoses And Masks,after Cleaning. This Device Is Not Intended To Replace The Original Accessory Manufacturers Cleaning Instructions..
| 510(k) Number | K243815 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 11, 2024 |
| Decision Date | October 10, 2025 |
| Days to Decision | 303 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | QXQ - Respiratory Accessory Microbial Reduction Device. |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.6993 |
| Definition | A Respiratory Accessory Microbial Reduction Device Is A Home-use Device Intended To Be Used As An Adjunct For Microbial Reduction Of Compatible Respiratory Accessories,such As Hoses And Masks,after Cleaning. This Device Is Not Intended To Replace The Original Accessory Manufacturers Cleaning Instructions. |