QXQ
- Product code
- QXQ
- Device name
- Respiratory Accessory Microbial Reduction Device.
- Device class
- Class 2
- 21 CFR
- 21 CFR 880.6993
- Medical specialty
- General Hospital
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 3
- Summaries archived here
- 2 (direct download)
- 510(k) clearances (all years, FDA)
- 3 (all years; only the last 3 years are listed here)
FDA classification 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.
510(k) clearances, last 3 years (3)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K252471 | 2026-04-29 | LiViliti Health Products Corporation | Paptizer 360 | |
| K243815 | 2025-10-10 | Soclean, Inc. | SoClean 3+ | |
| DEN210037 | 2024-08-12 | Soclean, Inc. | SoClean 3+ Bacterial Reduction Device | — |
Official FDA classification page: QXQ
Classification and pathway per current FDA publications. Data from openFDA (CC0).