FDA product code QIA: Powered Tongue Scraper
QIA is the FDA product code for powered tongue scraper. It is a Class I device, regulated under 21 CFR 872.6865 and reviewed by the Dental panel. FDA has cleared 1 510(k) submission under QIA. The average 510(k) review took 408 days (median 408).
Definition
The device is intended to remove debris from the top surface of the tongue as a supplement to normal daily oral hygiene care.
Classification
| Field | Value |
|---|---|
| Device name | Powered Tongue Scraper |
| Device class | Class I |
| Regulation | 21 CFR 872.6865 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) exempt |
510(k) clearances per year for QIA
| Year | Clearances | Avg. review days |
|---|---|---|
| 2019 | 1 | 408 |
Top QIA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Kea Products, Ltd. | 1 | 2019-09-06 |
Most recent QIA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K181986 | Kea Products, Ltd. | Klinly Ultrasonic Tongue Cleaner | 2019-09-06 | 408 |
Recalls for QIA devices
openFDA lists no recalls for product code QIA.
Frequently asked questions
What is FDA product code QIA?
QIA is the FDA product code for powered tongue scraper. It is a Class I device, regulated under 21 CFR 872.6865 and reviewed by the Dental panel.
What device class is QIA?
Class I, regulation 21 CFR 872.6865. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code QIA?
Across 1 cleared submissions the average was 408 days from receipt to decision (median 408).
Which companies have the most QIA clearances?
Kea Products, Ltd. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code QIA
- Run a recall and safety report across every QIA manufacturer
- Watch product code QIA 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.