FDA product code QTW: Digital Amsler Grid
QTW is the FDA product code for digital amsler grid. It is a Class I device, regulated under 21 CFR 886.1330 and reviewed by the Ophthalmic panel. FDA has cleared 1 510(k) submission under QTW, 1 in the last five years. The average 510(k) review took 637 days (median 637).
Definition
A Digital Amsler grid is intended as an aid in detection of central visual irregularities caused by changes in the visual pathway in patients.
Classification
| Field | Value |
|---|---|
| Device name | Digital Amsler Grid |
| Device class | Class I |
| Regulation | 21 CFR 886.1330 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) exempt |
510(k) clearances per year for QTW
| Year | Clearances | Avg. review days |
|---|---|---|
| 2022 | 1 | 637 |
Compare with all 510(k) review times · Search every QTW clearance
Top QTW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Neuro-Eye Diagnostic Systems, LLC | 1 | 2022-09-07 |
Most recent QTW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K203594 | Neuro-Eye Diagnostic Systems, LLC | EyeCTester | 2022-09-07 | 637 |
Recalls for QTW devices
openFDA lists no recalls for product code QTW.
Frequently asked questions
What is FDA product code QTW?
QTW is the FDA product code for digital amsler grid. It is a Class I device, regulated under 21 CFR 886.1330 and reviewed by the Ophthalmic panel.
What device class is QTW?
Class I, regulation 21 CFR 886.1330. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code QTW?
Across 1 cleared submissions the average was 637 days from receipt to decision (median 637).
Which companies have the most QTW clearances?
Neuro-Eye Diagnostic Systems, LLC (1).
Next steps
- Run an FDA pathway report with predicate devices for product code QTW
- Run a recall and safety report across every QTW manufacturer
- Watch product code QTW 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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