FDA product code SDW: Stationary Infrared Thermometer
SDW is the FDA product code for stationary infrared thermometer. It is a Class II device, regulated under 21 CFR 880.2910 and reviewed by the General Hospital panel. Devices under SDW reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Definition
A stationary infrared thermometer is a free-standing or mounted clinical electronic thermometer indicated to measure a persons body temperature. Under this regulation, this product code represents non-exempt devices. For more information, see 90 FR 25889, available at https://www.govinfo.gov/content/pkg/FR-2025-06-18/pdf/2025-11207.pdf.
Classification
| Field | Value |
|---|---|
| Device name | Stationary Infrared Thermometer |
| Device class | Class II |
| Regulation | 21 CFR 880.2910 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) |
Recalls for SDW devices
openFDA lists no recalls for product code SDW.
Frequently asked questions
What is FDA product code SDW?
SDW is the FDA product code for stationary infrared thermometer. It is a Class II device, regulated under 21 CFR 880.2910 and reviewed by the General Hospital panel.
What device class is SDW?
Class II, regulation 21 CFR 880.2910. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code SDW
- Run a recall and safety report across every SDW manufacturer
- Watch product code SDW 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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