FDA product code QTV: Mattress And Bed Deck Cover (Medical Purposes)
QTV is the FDA product code for mattress and bed deck cover (medical purposes). It is a Class I device, regulated under 21 CFR 880.6190 and reviewed by the General Hospital panel. FDA has cleared 1 510(k) submission under QTV, 1 in the last five years. The average 510(k) review took 786 days (median 786).
Definition
A mattress and bed deck cover for medical purposes is intended to provide a physical barrier between the patient and the mattress as well as all or parts of the bed deck or frame.
Classification
| Field | Value |
|---|---|
| Device name | Mattress And Bed Deck Cover (Medical Purposes) |
| Device class | Class I |
| Regulation | 21 CFR 880.6190 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) exempt |
510(k) clearances per year for QTV
| Year | Clearances | Avg. review days |
|---|---|---|
| 2022 | 1 | 786 |
Compare with all 510(k) review times · Search every QTV clearance
Top QTV applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Trinity Guardion | 1 | 2022-09-01 |
Most recent QTV clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K201876 | Trinity Guardion | Soteria Bed Barrier | 2022-09-01 | 786 |
Recalls for QTV devices
openFDA lists no recalls for product code QTV.
Frequently asked questions
What is FDA product code QTV?
QTV is the FDA product code for mattress and bed deck cover (medical purposes). It is a Class I device, regulated under 21 CFR 880.6190 and reviewed by the General Hospital panel.
What device class is QTV?
Class I, regulation 21 CFR 880.6190. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code QTV?
Across 1 cleared submissions the average was 786 days from receipt to decision (median 786).
Which companies have the most QTV clearances?
Trinity Guardion (1).
Next steps
- Run an FDA pathway report with predicate devices for product code QTV
- Run a recall and safety report across every QTV manufacturer
- Watch product code QTV 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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