FDA product code HKR: Lens, Maddox
HKR is the FDA product code for lens, maddox. It is a Class I device, regulated under 21 CFR 886.1400 and reviewed by the Ophthalmic panel. Devices under HKR reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Lens, Maddox |
| Device class | Class I |
| Regulation | 21 CFR 886.1400 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Recalls for HKR devices
openFDA lists no recalls for product code HKR.
Frequently asked questions
What is FDA product code HKR?
HKR is the FDA product code for lens, maddox. It is a Class I device, regulated under 21 CFR 886.1400 and reviewed by the Ophthalmic panel.
What device class is HKR?
Class I, regulation 21 CFR 886.1400. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code HKR
- Run a recall and safety report across every HKR manufacturer
- Watch product code HKR 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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