FDA product code HKD: Tape, Nystagmus
HKD is the FDA product code for tape, nystagmus. It is a Class I device, regulated under 21 CFR 886.1905 and reviewed by the Ophthalmic panel. Devices under HKD reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Tape, Nystagmus |
| Device class | Class I |
| Regulation | 21 CFR 886.1905 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Recalls for HKD devices
openFDA lists no recalls for product code HKD.
Frequently asked questions
What is FDA product code HKD?
HKD is the FDA product code for tape, nystagmus. It is a Class I device, regulated under 21 CFR 886.1905 and reviewed by the Ophthalmic panel.
What device class is HKD?
Class I, regulation 21 CFR 886.1905. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code HKD
- Run a recall and safety report across every HKD manufacturer
- Watch product code HKD 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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