FDA product code QKV: Electromechanical Tear Stimulator
QKV is the FDA product code for electromechanical tear stimulator. It is a Class II device, regulated under 21 CFR 886.5305 and reviewed by the Ophthalmic panel. FDA has cleared 1 510(k) submission under QKV, 1 in the last five years. The average 510(k) review took 120 days (median 120). 1 De Novo request was granted under it.
Definition
This device type is a non-implantable device intended to increase tear production via mechanical stimulation.
Classification
| Field | Value |
|---|---|
| Device name | Electromechanical Tear Stimulator |
| Device class | Class II |
| Regulation | 21 CFR 886.5305 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) |
510(k) clearances per year for QKV
| Year | Clearances | Avg. review days |
|---|---|---|
| 2022 | 1 | 120 |
Top QKV applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Olympic Ophthalmics | 1 | 2022-03-16 |
Most recent QKV clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K213623 | Olympic Ophthalmics | iTEAR100 Neurostimulator | 2022-03-16 | 120 |
Recalls for QKV devices
openFDA lists no recalls for product code QKV.
Frequently asked questions
What is FDA product code QKV?
QKV is the FDA product code for electromechanical tear stimulator. It is a Class II device, regulated under 21 CFR 886.5305 and reviewed by the Ophthalmic panel.
What device class is QKV?
Class II, regulation 21 CFR 886.5305. Typical premarket route: 510(k).
How long does a 510(k) take for product code QKV?
Across 1 cleared submissions the average was 120 days from receipt to decision (median 120).
Which companies have the most QKV clearances?
Olympic Ophthalmics (1).
Next steps
- Run an FDA pathway report with predicate devices for product code QKV
- Run a recall and safety report across every QKV manufacturer
- Watch product code QKV 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.