QXQClass II
Respiratory Accessory Microbial Reduction Device.
21 CFR 880.6993 / General Hospital
QXQ is the FDA product code for Respiratory Accessory Microbial Reduction Device., a class II device type, regulated under 21 CFR 880.6993. FDA's definition for this code reads: "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". As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and 2 recalls.
Classification record
- Product code
- QXQ
- Device name
- Respiratory Accessory Microbial Reduction Device.
- 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 manufacturer’s cleaning instructions.
- Regulation
- 21 CFR 880.6993
- Device class
- Class II
- Review panel
- General Hospital
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 3
- Ingested recalls
- 2
Clearances, product code QXQ
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2024 | 1 |
| 2025 | 1 |
| 2026 | 1 |
Applicants with the most clearances
Product code QXQ| Applicant | Clearances |
|---|---|
| SoClean, Inc. | 2 |
| Liviliti Health Products Corp | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.