FDA product code QXJ: Whole Room Microbial Reduction Device
QXJ is the FDA product code for whole room microbial reduction device. It is a Class II device, regulated under 21 CFR 880.6510 and reviewed by the General Hospital panel. FDA has cleared 1 510(k) submission under QXJ, 1 in the last five years. The average 510(k) review took 270 days (median 270); 270 days on average over the last three years. 1 De Novo request was granted under it. FDA has posted 1 recall for QXJ devices, 1 initiated in the last five years.
Definition
A whole room microbial reduction device is a medical device to be used to reduce microbial load on medical device surfaces following cleaning and disinfection.
Classification
| Field | Value |
|---|---|
| Device name | Whole Room Microbial Reduction Device |
| Device class | Class II |
| Regulation | 21 CFR 880.6510 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) |
510(k) clearances per year for QXJ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2025 | 1 | 270 |
Compare with all 510(k) review times · Search every QXJ clearance
Top QXJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Preventamed Technologies, Inc. Dba Surfacide Manufacturing | 1 | 2025-05-27 |
Most recent QXJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K242604 | Preventamed Technologies, Inc. Dba Surfacide Manufacturing | Helios+ UV-C System | 2025-05-27 | 270 |
Recalls for QXJ devices
1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2024-03-18.
| Year | Recalls |
|---|---|
| 2024 | 1 |
Frequently asked questions
What is FDA product code QXJ?
QXJ is the FDA product code for whole room microbial reduction device. It is a Class II device, regulated under 21 CFR 880.6510 and reviewed by the General Hospital panel.
What device class is QXJ?
Class II, regulation 21 CFR 880.6510. Typical premarket route: 510(k).
How long does a 510(k) take for product code QXJ?
Across 1 cleared submissions the average was 270 days from receipt to decision (median 270).
Which companies have the most QXJ clearances?
Preventamed Technologies, Inc. Dba Surfacide Manufacturing (1).
Have QXJ devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2024-03-18.
Next steps
- Run an FDA pathway report with predicate devices for product code QXJ
- Run a recall and safety report across every QXJ manufacturer
- Watch product code QXJ 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