FDA product code SDV: Clinical Electronic Thermometer
SDV is the FDA product code for clinical electronic thermometer. It is a Class II device, regulated under 21 CFR 880.2910 and reviewed by the General Hospital panel. Devices under SDV reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Definition
A clinical electronic thermometer is a device used to intermittently measure the body temperature of a patient by means of a transducer coupled with an electronic signal amplification, conditioning, and display unit. This product code is class II exempt, and was exempted, subject to the limitations of exemption, under the procedures established by section 510(m) of the FD&C Act. This device type does not require premarket notification (510(k)) to market if it does not exceed the general limitations of exemption found in 21 CFR 880.9 and the specific limitations of exemption as stated in the final order, 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 | Clinical Electronic Thermometer |
| Device class | Class II |
| Regulation | 21 CFR 880.2910 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) exempt |
Recalls for SDV devices
openFDA lists no recalls for product code SDV.
Frequently asked questions
What is FDA product code SDV?
SDV is the FDA product code for clinical electronic thermometer. It is a Class II device, regulated under 21 CFR 880.2910 and reviewed by the General Hospital panel.
What device class is SDV?
Class II, regulation 21 CFR 880.2910. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code SDV
- Run a recall and safety report across every SDV manufacturer
- Watch product code SDV 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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