FDA product code DGW: System, Test, Hypersensitivity Pneumonitis
DGW is the FDA product code for system, test, hypersensitivity pneumonitis. It is a Class II device, regulated under 21 CFR 866.5500 and reviewed by the Immunology panel. Devices under DGW reach the market by 510(k); FDA lists no cleared 510(k)s for it. FDA has posted 2 recalls for DGW devices, 2 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | System, Test, Hypersensitivity Pneumonitis |
| Device class | Class II |
| Regulation | 21 CFR 866.5500 |
| Review panel | IM — Immunology |
| Medical specialty | Immunology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Recalls for DGW devices
2 product recalls in 1 recall events; 2 initiated in the last five years and 0 still open. Most recent: 2022-10-25.
| Year | Recalls |
|---|---|
| 2022 | 2 |
Frequently asked questions
What is FDA product code DGW?
DGW is the FDA product code for system, test, hypersensitivity pneumonitis. It is a Class II device, regulated under 21 CFR 866.5500 and reviewed by the Immunology panel.
What device class is DGW?
Class II, regulation 21 CFR 866.5500. Typical premarket route: 510(k).
Have DGW devices been recalled?
Yes: 2 product recalls across 1 recall events; the most recent began 2022-10-25.
Next steps
- Run an FDA pathway report with predicate devices for product code DGW
- Run a recall and safety report across every DGW manufacturer
- Watch product code DGW 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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