Fever Tester
by American Thermometer Company, Inc.
510(k) K771980
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK771980 | Date2 Nov 1977 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- KPD
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.2200
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Fever Tester is a Temperature, Forehead, Liquid Crystal Strip, a single-use diagnostic device designed to measure body temperature non-invasively. It falls under the classification of a liquid crystal thermometer, providing a visual indication of fever via color change on the strip when applied to the forehead. This device is intended for general hospital use and operates on the principle of liquid crystal thermometry, where temperature-sensitive crystals alter color in response to heat.
The Fever Tester is supplied as a single-use strip and is intended for one-time application. It is not sterile and requires no special handling beyond proper storage in a cool, dry environment to maintain functionality. The device is classified as Class II under FDA regulations and was granted FDA 510(k) clearance under the Traditional pathway in 1977 (K771980). No MRI safety information is provided, and its use is restricted to non-invasive temperature assessment in general hospital settings.
Other devices from American Thermometer Company, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Fever Tester used for?
The Fever Tester is a single-use, non-invasive diagnostic device designed to measure body temperature by detecting fever through a color change on a liquid crystal strip when applied to the forehead. It provides a visual indication of elevated temperature, helping clinicians quickly assess whether a patient may have a fever without invasive methods.
How is the Fever Tester supplied and how should it be stored?
The Fever Tester comes as a single-use strip, meaning each strip is intended for one-time use only. It does not require special handling beyond proper storage in a cool, dry environment to maintain its functionality. Avoid exposure to extreme temperatures or moisture, as this could affect the accuracy of the liquid crystal thermometry.
Is the Fever Tester sterile, and can it be reused?
No, the Fever Tester is not sterile and is explicitly designed for single-use only. Reusing the strip could compromise accuracy and introduce contamination risks, which is why it is not recommended. Always use a new strip for each patient assessment.
What are the key specifications or models associated with this device?
The Fever Tester is classified under the product code KPD and falls under the OpenFDA category for 'Strip, Temperature, Forehead, Liquid Crystal.' It was granted FDA 510(k) clearance under the Traditional pathway in 1977 (K771980) and is intended for general hospital use. Multiple registration numbers (e.g., 3013557562) are associated with this device, reflecting its distribution across various hospital settings.
Is the Fever Tester safe for use in MRI environments?
No MRI safety information is provided for the Fever Tester. Its use is restricted to non-invasive temperature assessment in general hospital settings, and it should not be used in or near MRI machines unless explicitly approved for such environments. Always verify compatibility with the specific MRI system in use.