BD Flexible Digital Thermometer

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K902624 ↗

FDA Product Code

FLL

Device Class

Class II

Regulation

21 CFR Part 880.2910

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

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• What is the BD Flexible Digital Thermometer used for?

  The BD Flexible Digital Thermometer is designed for continuous measurement of a patient’s core body temperature. Its flexible design allows for precise readings in clinical settings, making it ideal for monitoring patients in general hospital environments. The device is particularly useful where rapid and reliable temperature assessment is required, such as in intensive care or post-operative recovery.

• How is the BD Flexible Digital Thermometer supplied and prepared for use?

  The thermometer is supplied sterile and intended for single-use only. This ensures patient safety by eliminating cross-contamination risks. Before use, follow standard sterile device protocols, such as opening the packaging with sterile gloves and handling the device only at its designated attachment points to maintain sterility.

• Is the BD Flexible Digital Thermometer reusable, or is it meant for one-time use?

  The device is explicitly designed for one-time use only. Its single-use classification aligns with regulatory standards for Class 2 medical devices, ensuring hygiene and reducing the risk of infection transmission. Reuse is not recommended or supported by the manufacturer.

• Are there specific storage requirements for the BD Flexible Digital Thermometer?

  Beyond standard sterile device protocols, no additional storage requirements are specified for the BD Flexible Digital Thermometer. It should be stored in its original packaging until use, in a clean, dry environment protected from physical damage or contamination. Ensure the device remains within its expiration date to guarantee accuracy and reliability.

• What distinguishes the BD Flexible Digital Thermometer from other digital thermometers?

  The BD Flexible Digital Thermometer is distinguished by its classification as a continuous measurement device, which allows for ongoing temperature tracking rather than single-point readings. Its flexible design enhances adaptability for various clinical applications, and it is FDA 510(k) cleared under the Traditional pathway for use in general hospital settings. Additionally, its single-use, sterile packaging aligns with high hygiene standards in medical environments.