FDA product code HPK: Tonograph
HPK is the FDA product code for tonograph. It is a Class II device, regulated under 21 CFR 886.1930 and reviewed by the Ophthalmic panel. Devices under HPK reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Tonograph |
| Device class | Class II |
| Regulation | 21 CFR 886.1930 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Recalls for HPK devices
openFDA lists no recalls for product code HPK.
Frequently asked questions
What is FDA product code HPK?
HPK is the FDA product code for tonograph. It is a Class II device, regulated under 21 CFR 886.1930 and reviewed by the Ophthalmic panel.
What device class is HPK?
Class II, regulation 21 CFR 886.1930. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code HPK
- Run a recall and safety report across every HPK manufacturer
- Watch product code HPK 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.