RII Infrared Ear Thermometer, Models THXXN Series
by Radiant Innovation Inc. 510(k)
Active
510(k) K040377
Overview
The RII Infrared Ear Thermometer, Models THXXN Series, is an infrared-based electronic thermometer classified as a non-contact ear thermometer (FDA Product Code: FLL). It employs an infrared detector (thermopile detector) to measure body temperature by detecting infrared radiation emitted from the eardrum, enabling rapid, non-invasive readings without physical contact.
This device is intended for use in general hospital settings and has received FDA 510(k) clearance under a Special Review pathway, demonstrating substantial equivalence to a predicate device. Supplied as a reusable medical instrument, it requires proper calibration and maintenance as specified by the manufacturer. The thermometer is not designed for MRI environments and must be stored in a clean, dry environment to preserve functionality.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK040377 | Date16 Sep 2004 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- FLL
- FDA applicant
- Radiant Innovation, Inc.
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.2910
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
From the manufacturer
Infrared ear thermometer with accurate sensor receives the signal emitted by the eardrum temperature without touching to take the body temperature.
Other devices from Radiant Innovation Inc.
Questions
Is this thermometer designed for single-use or reusable in clinical settings, and what maintenance is required?
The RII Infrared Ear Thermometer (Models THXXN Series) is reusable and intended for use in general hospital environments. Since it is classified as a reusable medical instrument, it requires proper calibration and maintenance as outlined by Radiant Innovation Inc. to ensure accurate readings and longevity. The manufacturer’s instructions should be followed to clean and store the device properly, as it must be kept in a clean, dry environment to maintain functionality.
How does this device measure temperature, and why is it considered non-contact?
This thermometer uses an infrared detector (thermopile detector) to measure body temperature by detecting the infrared radiation emitted from the eardrum. Because it does not require physical contact with the ear canal, it is classified as a non-contact ear thermometer, allowing for rapid, hygienic readings without direct touch.
What regulatory pathway was followed for FDA clearance, and what does that mean for its use?
The RII Infrared Ear Thermometer received FDA 510(k) clearance under a Special Review pathway, specifically demonstrating substantial equivalence to a predicate device. This means it was evaluated by the FDA as meeting the same performance standards as an existing approved device, ensuring its safety and effectiveness for use in general hospital settings as intended. The clearance does not imply any specific clinical indication beyond what is stated in the device description.
Can this thermometer be used in environments with MRI machines, and why or why not?
No, this device is not designed for MRI environments. The manufacturer explicitly states it must not be used in such settings, likely due to potential electromagnetic interference or safety risks associated with magnetic fields. Always follow the manufacturer’s guidelines to avoid compromising device performance or patient safety.
What storage conditions are required to keep this thermometer functional over time?
To preserve functionality, the RII Infrared Ear Thermometer must be stored in a clean and dry environment. Avoid exposure to moisture, extreme temperatures, or contaminants, as these could affect calibration or performance. Proper storage also helps maintain the device’s accuracy and longevity for reusable clinical use.