FDA product code HOK: Screen, Tangent, Projection, Ac-Powered
HOK is the FDA product code for screen, tangent, projection, ac-powered. It is a Class I device, regulated under 21 CFR 886.1810 and reviewed by the Ophthalmic panel. FDA has cleared 1 510(k) submission under HOK. The average 510(k) review took 84 days (median 84).
Classification
| Field | Value |
|---|---|
| Device name | Screen, Tangent, Projection, Ac-Powered |
| Device class | Class I |
| Regulation | 21 CFR 886.1810 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every HOK clearance
Top HOK applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Clement Clarke, Inc. | 1 | 1992-01-23 |
Most recent HOK clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K914896 | Clement Clarke, Inc. | FRIEDMANN ANALYSER 3 | 1992-01-23 | 84 |
Recalls for HOK devices
openFDA lists no recalls for product code HOK.
Frequently asked questions
What is FDA product code HOK?
HOK is the FDA product code for screen, tangent, projection, ac-powered. It is a Class I device, regulated under 21 CFR 886.1810 and reviewed by the Ophthalmic panel.
What device class is HOK?
Class I, regulation 21 CFR 886.1810. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HOK?
Across 1 cleared submissions the average was 84 days from receipt to decision (median 84).
Which companies have the most HOK clearances?
Clement Clarke, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code HOK
- Run a recall and safety report across every HOK manufacturer
- Watch product code HOK 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.
All Ophthalmic product codes · FDA product code lookup · 510(k) database search · 510(k) review times