FDA product code IDY: Bath, Flotation, Tissue
IDY is the FDA product code for bath, flotation, tissue. It is a Class I device, regulated under 21 CFR 864.3010 and reviewed by the Pathology panel. Devices under IDY reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it. FDA has posted 1 recall for IDY devices.
Classification
| Field | Value |
|---|---|
| Device name | Bath, Flotation, Tissue |
| 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 IDY devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2008-05-01.
Frequently asked questions
What is FDA product code IDY?
IDY is the FDA product code for bath, flotation, tissue. It is a Class I device, regulated under 21 CFR 864.3010 and reviewed by the Pathology panel.
What device class is IDY?
Class I, regulation 21 CFR 864.3010. Typical premarket route: 510(k) exempt.
Have IDY devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2008-05-01.
Next steps
- Run an FDA pathway report with predicate devices for product code IDY
- Run a recall and safety report across every IDY manufacturer
- Watch product code IDY 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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