Product code QXQ
- Device name
- Respiratory Accessory Microbial Reduction Device.
- Medical specialty
- General Hospital
- Device class
- 2
- Regulation number
- 880.6993
- Review panel
- HO
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- 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 manufacturerÂ’s cleaning instructions.
- Source
- FDA openFDA device classification dataset
Related 510(k) Records
| 510(k) | Device | Applicant | Decision date |
|---|
| K252471 | Paptizer 360 | LiViliti Health Products Corporation | 2026-04-29 |
| K243815 | SoClean 3+ | Soclean, Inc. | 2025-10-10 |
| DEN210037 | SoClean 3+ Bacterial Reduction Device | Soclean, Inc. | 2024-08-12 |