FDA product code KND: Heater, Perineal
KND is the FDA product code for heater, perineal. It is a Class II device, regulated under 21 CFR 884.5390 and reviewed by the Obstetrics and Gynecology panel. Devices under KND reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Heater, Perineal |
| Device class | Class II |
| Regulation | 21 CFR 884.5390 |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | 510(k) exempt |
Recalls for KND devices
openFDA lists no recalls for product code KND.
Frequently asked questions
What is FDA product code KND?
KND is the FDA product code for heater, perineal. It is a Class II device, regulated under 21 CFR 884.5390 and reviewed by the Obstetrics and Gynecology panel.
What device class is KND?
Class II, regulation 21 CFR 884.5390. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code KND
- Run a recall and safety report across every KND manufacturer
- Watch product code KND 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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