FDA product code OHY: Pill Crusher/Cutter
OHY is the FDA product code for pill crusher/cutter. It is a Class I device, regulated under 21 CFR 880.6430 and reviewed by the General Hospital panel. Devices under OHY reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it. FDA has posted 1 recall for OHY devices, 1 initiated in the last five years.
Definition
A device used to cut or crush medication to aid in consumption. The device is intended to only be used with medications that are labeled as acceptable for crushing or cutting.
Classification
| Field | Value |
|---|---|
| Device name | Pill Crusher/Cutter |
| Device class | Class I |
| Regulation | 21 CFR 880.6430 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) exempt |
Recalls for OHY devices
1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2022-05-11.
| Year | Recalls |
|---|---|
| 2022 | 1 |
Frequently asked questions
What is FDA product code OHY?
OHY is the FDA product code for pill crusher/cutter. It is a Class I device, regulated under 21 CFR 880.6430 and reviewed by the General Hospital panel.
What device class is OHY?
Class I, regulation 21 CFR 880.6430. Typical premarket route: 510(k) exempt.
Have OHY devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2022-05-11.
Next steps
- Run an FDA pathway report with predicate devices for product code OHY
- Run a recall and safety report across every OHY manufacturer
- Watch product code OHY 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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