QXQ
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Respiratory Accessory Microbial Reduction Device.
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.6993
- Medical specialty
- General Hospital
- FDA 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.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Paptizer 360 (K252471) | LiViliti Health Products Corporation | 2026-04-29 |
| SoClean 3+ (K243815) | Soclean, Inc. | 2025-10-10 |
| SoClean 3+ Bacterial Reduction Device (DEN210037) | Soclean, Inc. | 2024-08-12 |
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Every clearance here is in the API, with alerts when new ones post.