510(k) K252471
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 29, 2026
- Date Received
- August 6, 2025
- 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.