510(k) K243815
K243815 is an FDA 510(k) premarket notification submitted by Soclean, Inc. for the device "SoClean 3+". The FDA issued a decision of Substantially Equivalent on October 10, 2025. The device falls under product code QXQ (Respiratory Accessory Microbial Reduction Device.), a Class II device regulated under 21 CFR 880.6993. Soclean, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 10, 2025
- Date Received
- December 11, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Respiratory Accessory Microbial Reduction Device.
- Device Class
- Class II
- Regulation Number
- 880.6993
- Review Panel
- HO
- Submission Type
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.