FDA product code HRI: Pupillograph
HRI is the FDA product code for pupillograph. It is a Class I device, regulated under 21 CFR 886.1690 and reviewed by the Ophthalmic panel. Devices under HRI reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Pupillograph |
| Device class | Class I |
| Regulation | 21 CFR 886.1690 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) exempt |
Recalls for HRI devices
openFDA lists no recalls for product code HRI.
Frequently asked questions
What is FDA product code HRI?
HRI is the FDA product code for pupillograph. It is a Class I device, regulated under 21 CFR 886.1690 and reviewed by the Ophthalmic panel.
What device class is HRI?
Class I, regulation 21 CFR 886.1690. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code HRI
- Run a recall and safety report across every HRI manufacturer
- Watch product code HRI 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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