FDA product code QWS: Foam Or Gel Chemical Sterilant/High Level Disinfectant
QWS is the FDA product code for foam or gel chemical sterilant/high level disinfectant. It is a Class II device, regulated under 21 CFR 880.6886 and reviewed by the General Hospital panel. FDA has cleared 1 510(k) submission under QWS, 1 in the last five years. The average 510(k) review took 241 days (median 241); 241 days on average over the last three years. 1 De Novo request was granted under it.
Definition
A foam or gel chemical sterilant/high level disinfectant is a germicide in the form of a foam or gel that is intended for use as the terminal step in high level disinfection of medical devices prior to patient use.
Classification
| Field | Value |
|---|---|
| Device name | Foam Or Gel Chemical Sterilant/High Level Disinfectant |
| Device class | Class II |
| Regulation | 21 CFR 880.6886 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) |
510(k) clearances per year for QWS
| Year | Clearances | Avg. review days |
|---|---|---|
| 2025 | 1 | 241 |
Compare with all 510(k) review times · Search every QWS clearance
Top QWS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Tristel Solutions , Ltd. | 1 | 2025-05-09 |
Most recent QWS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K242732 | Tristel Solutions , Ltd. | Tristel OPH | 2025-05-09 | 241 |
Recalls for QWS devices
openFDA lists no recalls for product code QWS.
Frequently asked questions
What is FDA product code QWS?
QWS is the FDA product code for foam or gel chemical sterilant/high level disinfectant. It is a Class II device, regulated under 21 CFR 880.6886 and reviewed by the General Hospital panel.
What device class is QWS?
Class II, regulation 21 CFR 880.6886. Typical premarket route: 510(k).
How long does a 510(k) take for product code QWS?
Across 1 cleared submissions the average was 241 days from receipt to decision (median 241).
Which companies have the most QWS clearances?
Tristel Solutions , Ltd. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code QWS
- Run a recall and safety report across every QWS manufacturer
- Watch product code QWS 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.
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