FDA product code IDQ: Infiltrator
IDQ is the FDA product code for infiltrator. It is a Class I device, regulated under 21 CFR 864.3010 and reviewed by the Pathology panel. Devices under IDQ reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Infiltrator |
| 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 IDQ devices
openFDA lists no recalls for product code IDQ.
Frequently asked questions
What is FDA product code IDQ?
IDQ is the FDA product code for infiltrator. It is a Class I device, regulated under 21 CFR 864.3010 and reviewed by the Pathology panel.
What device class is IDQ?
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 IDQ
- Run a recall and safety report across every IDQ manufacturer
- Watch product code IDQ 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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