FDA product code KDZ: Device, Decalcifier, Electrolytic
KDZ is the FDA product code for device, decalcifier, electrolytic. It is a Class I device, regulated under 21 CFR 864.3010 and reviewed by the Pathology panel. Devices under KDZ reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Device, Decalcifier, Electrolytic |
| Device class | Class I |
| Regulation | 21 CFR 864.3010 |
| Review panel | PA — Pathology |
| Medical specialty | Pathology |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Recalls for KDZ devices
openFDA lists no recalls for product code KDZ.
Frequently asked questions
What is FDA product code KDZ?
KDZ is the FDA product code for device, decalcifier, electrolytic. It is a Class I device, regulated under 21 CFR 864.3010 and reviewed by the Pathology panel.
What device class is KDZ?
Class I, regulation 21 CFR 864.3010. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code KDZ
- Run a recall and safety report across every KDZ manufacturer
- Watch product code KDZ 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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