QXQ · Respiratory Accessory Microbial Reduction Device.
General Hospital · 21 CFR 880.6993 · Class 2
Overview
| Product Code | QXQ |
|---|---|
| Device Name | Respiratory Accessory Microbial Reduction Device. |
| Regulation | 21 CFR 880.6993 |
| Device Class | Class 2 |
| Review Panel | General Hospital |
Identification
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 manufacturer's cleaning instructions.
Classification Rationale
Class II (special controls). The device is classified as Class II because the probable benefits outweigh the probable risks, and the risks can be mitigated using general controls and the identified special controls.
Special Controls
In combination with the general controls of the FD&C Act, the respiratory accessory microbial reduction device is subject to the following special controls:
Recent Cleared Devices (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K243815 | SoClean 3+ | Soclean, Inc. | Oct 10, 2025 | SESE |
| DEN210037 | SoClean 3+ Bacterial Reduction Device | Soclean, Inc. | Aug 12, 2024 | DENG |
Top Applicants
- Soclean, Inc. — 2 clearances
