E-Z Therm 3 Second Thermometer

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K932204 ↗

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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See all devices from North American Technical Services Corp. →

• How quickly does the E-Z Therm 3 Second Thermometer provide a temperature reading, and is this speed consistent across all use cases?

  The E-Z Therm 3 Second Thermometer delivers a temperature reading in three seconds, as indicated by its name. This rapid response time is designed for both clinical and home settings, ensuring quick assessment of fever or hypothermia without compromising accuracy. The device’s claim to ‘rapid-read’ suggests this speed is consistent for oral measurements under normal use conditions.

• Can this thermometer be reused, or is it intended for single-use only? How does sterility factor into its use?

  The E-Z Therm 3 Second Thermometer is intended for both single-use and reusable applications, particularly in general hospital environments. Sterility is not a default setting—it must be specified by the user, meaning it can be supplied sterile or non-sterile based on clinical needs. Reusable models would require proper cleaning and disinfection between uses, while single-use models would be discarded after one measurement.

• What regulatory pathway was followed for this device, and which advisory committee reviewed its submission?

  The E-Z Therm 3 Second Thermometer underwent FDA 510(k) clearance under the traditional review pathway, with a decision code of SESE (Substantially Equivalent). Its submission was reviewed by the General Hospital (HO) Advisory Committee, which categorizes it under product code FLL (thermometers). The clearance number is K932204, filed in 1993 and finalized in 1994.

• Are there different models or sizes available for the E-Z Therm 3 Second Thermometer, or is it a single unified design?

  The provided data does not specify multiple models or sizes for the E-Z Therm 3 Second Thermometer. It is described as a single rapid-read oral thermometer, implying a standardized design for general use. If variations exist (e.g., pediatric vs. adult probes), they are not detailed in the available information.