FDA product code HKZ: Sterilizer, Tonometer
HKZ is the FDA product code for sterilizer, tonometer. It is a Class I device, regulated under 21 CFR 886.1940 and reviewed by the Ophthalmic panel. Devices under HKZ reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Sterilizer, Tonometer |
| Device class | Class I |
| Regulation | 21 CFR 886.1940 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) exempt |
Recalls for HKZ devices
openFDA lists no recalls for product code HKZ.
Frequently asked questions
What is FDA product code HKZ?
HKZ is the FDA product code for sterilizer, tonometer. It is a Class I device, regulated under 21 CFR 886.1940 and reviewed by the Ophthalmic panel.
What device class is HKZ?
Class I, regulation 21 CFR 886.1940. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code HKZ
- Run a recall and safety report across every HKZ manufacturer
- Watch product code HKZ 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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