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Thermometer, Exacta Temp

by S.M.B. Celsius Co., Inc. 510(k)

Active United States

510(k) K781106

Overview

The Thermometer, Exacta Temp is a device used to measure body temperature. It is a clinical mercury thermometer, which uses the thermal expansion of mercury to measure oral, rectal, or axillary body temperature.

The Thermometer, Exacta Temp is supplied with an FDA 510K authorization and is classified as a Class II device with special controls. It is used in a general hospital setting and has a product code of FLK. The device has a regulation number of 880.2920 and is registered with the FDA.

AI-generated from registry data, 1 Oct 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK781106 Date10 Aug 1978ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 6 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
FLK
Device Class
Class II
Regulation
21 CFR Part 880.2920
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Questions

  • What is the Thermometer Exacta Temp used for?

    The Thermometer Exacta Temp is used to measure body temperature by detecting the thermal expansion of mercury in response to heat, allowing for oral, rectal, or axillary temperature readings in clinical settings.

  • How is the Thermometer Exacta Temp supplied and is it reusable?

    The Thermometer Exacta Temp is supplied as a standalone clinical mercury thermometer and is designed for reuse after proper cleaning and disinfection, as it is not marked as single-use in the provided data.

  • What regulatory pathway was used for the Thermometer Exacta Temp?

    The Thermometer Exacta Temp received FDA 510(k) authorization through a traditional submission process, demonstrating substantial equivalence to a legally marketed predicate device.