FDA product code QXQ: Respiratory Accessory Microbial Reduction Device.
QXQ is the FDA product code for respiratory accessory microbial reduction device.. It is a Class II device, regulated under 21 CFR 880.6993 and reviewed by the General Hospital panel. FDA has cleared 2 510(k) submissions under QXQ, 2 in the last five years, from 2 different applicants. The average 510(k) review took 284 days (median 284); 284 days on average over the last three years. 1 De Novo request was granted under it. FDA has posted 2 recalls for QXQ devices, 2 initiated in the last five years.
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.
Classification
| Field | Value |
|---|---|
| Device name | Respiratory Accessory Microbial Reduction Device. |
| Device class | Class II |
| Regulation | 21 CFR 880.6993 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) |
510(k) clearances per year for QXQ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2025 | 1 | 303 |
| 2026 | 1 | 266 |
Compare with all 510(k) review times · Search every QXQ clearance
Top QXQ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| LiViliti Health Products Corporation | 1 | 2026-04-29 |
| Soclean, Inc. | 1 | 2025-10-10 |
Most recent QXQ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K252471 | LiViliti Health Products Corporation | Paptizer 360 | 2026-04-29 | 266 |
| K243815 | Soclean, Inc. | SoClean 3+ | 2025-10-10 | 303 |
Recalls for QXQ devices
2 product recalls in 1 recall events; 2 initiated in the last five years and 2 still open. Most recent: 2023-11-15.
| Year | Recalls |
|---|---|
| 2023 | 2 |
Frequently asked questions
What is FDA product code QXQ?
QXQ is the FDA product code for respiratory accessory microbial reduction device.. It is a Class II device, regulated under 21 CFR 880.6993 and reviewed by the General Hospital panel.
What device class is QXQ?
Class II, regulation 21 CFR 880.6993. Typical premarket route: 510(k).
How long does a 510(k) take for product code QXQ?
Across 2 cleared submissions the average was 284 days from receipt to decision (median 284).
Which companies have the most QXQ clearances?
LiViliti Health Products Corporation (1); Soclean, Inc. (1).
Have QXQ devices been recalled?
Yes: 2 product recalls across 1 recall events; the most recent began 2023-11-15.
Next steps
- Run an FDA pathway report with predicate devices for product code QXQ
- Run a recall and safety report across every QXQ manufacturer
- Watch product code QXQ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
All General Hospital product codes · FDA product code lookup · 510(k) database search · 510(k) review times