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TemporalScanner Thermometer SensorTouch

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K011291

by Exergen Corporation

Identifiers

510(k) Number
K011291 FDA 510(k)
FDA Product Code
FLL FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 880.2910 FDA 510(k)
Regulation Number
880.2910 FDA 510(k)
Advisory Committee
General Hospital FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The TemporalScanner Thermometer SensorTouch is a non-invasive, infrared temporal artery thermometer designed to measure core body temperature by scanning the forehead. It utilises advanced sensor technology to provide rapid and accurate readings, suitable for clinical and home use.

This device is supplied as a reusable, non-sterile instrument and is intended for single-patient use per manufacturer guidelines. It is authorised under FDA 510K and MDR, with a product code of FLL. The device requires no special storage conditions beyond protection from physical damage and extreme temperatures, and its sensor design ensures compatibility with standard clinical environments.

Frequently asked questions

How is the TemporalScanner Thermometer SensorTouch intended to be used in clinical settings, and what makes it suitable for both home and hospital environments?

The TemporalScanner Thermometer SensorTouch is a non-invasive, infrared device that measures core body temperature by scanning the forehead. Its advanced sensor technology ensures rapid and accurate readings, making it versatile for both clinical and home use. The reusable design aligns with standard clinical environments, while its single-patient-use guidelines per manufacturer recommendations ensure hygiene and safety in shared settings like hospitals.

Is the TemporalScanner Thermometer SensorTouch sterile, and if not, what are the manufacturer’s guidelines for reuse and cleaning?

The TemporalScanner Thermometer SensorTouch is supplied as a non-sterile device and is intended for single-patient use per manufacturer guidelines. While reusable, it is not designed for repeated use without proper cleaning between patients. The manufacturer does not specify cleaning protocols in the provided data, so users should follow standard clinical disinfection practices to maintain hygiene and functionality.

What storage requirements does the TemporalScanner Thermometer SensorTouch have, and how should it be protected?

The device requires no special storage conditions beyond protection from physical damage and extreme temperatures. Since it is reusable, it should be stored in a clean, dry environment away from direct sunlight or moisture to preserve its sensor integrity and ensure accurate readings when in use.

What regulatory pathways has the TemporalScanner Thermometer SensorTouch undergone, and what does that mean for its use in different markets?

The device has been authorized through FDA 510K clearance (traditional pathway, substantially equivalent determination) and MDR (Medical Device Regulation) compliance. This means it meets regulatory standards for safety and performance in the U.S. and EU markets, respectively, though final market availability depends on local regulatory acceptance and distribution agreements.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Exergen TemporalScanner TAT-5000 Reference Manual, Home Page - Exergen Corporation, Exergen Product Manual - Exergen Corporation, Amazon.com: Exergen Temporal Scanner Thermometer, Exergen TemporalScanner Contact Thermometers - Medline

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Exergen Corporation
FDA Applicant
Exergen Corp.

Sources (2)

  • FDA 510(k) K011291 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced Jun 1, 2026