RII Infrared Ear Thermometer, Model TH60N
by Radiant Innovation Inc. Taiwan 510(k)
510(k) K101253 Product code FLL
Overview
The RII Infrared Ear Thermometer, Model TH60N, is a non-contact infrared thermometer designed for measuring body temperature via the ear canal. It falls under the category of ear thermometers and operates by detecting infrared radiation emitted from the tympanic membrane, providing rapid and accurate temperature readings for clinical use.
This device is intended for single-use or reusable applications in general hospital settings, depending on manufacturer guidelines. Supplied sterile or non-sterile as specified by the user, it adheres to FDA clearance under 510(k) classification K101253. The thermometer is intended for use in environments where precise temperature monitoring is required, such as patient assessment, and is regulated under the product code FLL.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK101253 | Date29 Jun 2010 | 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- Withdrawn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
Other devices from Radiant Innovation Inc.
Questions
How does the RII Infrared Ear Thermometer (Model TH60N) determine body temperature, and why is this method preferred in clinical settings?
The RII Infrared Ear Thermometer (Model TH60N) measures body temperature by detecting infrared radiation emitted from the tympanic membrane (eardrum) in the ear canal. This method is preferred in clinical settings because it provides rapid, non-invasive readings without requiring physical contact with the patient, reducing the risk of cross-contamination and allowing for quick assessments in busy environments like hospitals.
Is the RII Infrared Ear Thermometer (Model TH60N) intended for single-use or reusable applications, and how should it be prepared for use?
The RII Infrared Ear Thermometer (Model TH60N) is designed for both single-use and reusable applications, depending on the facility’s guidelines. If sterile use is required, the device must be supplied or processed in a sterile manner by the user. For reusable models, proper cleaning and disinfection protocols must be followed to ensure accuracy and safety between uses.
What regulatory pathway was followed for FDA clearance of the RII Infrared Ear Thermometer (Model TH60N), and what does this mean for its clinical use?
The RII Infrared Ear Thermometer (Model TH60N) received FDA clearance under a 510(k) submission (K101253), classified as substantially equivalent to a predicate device. This clearance was granted by the Hospital/Outpatient (HO) Advisory Committee and falls under product code FLL (Ear Thermometers). The clearance confirms the device meets FDA safety and performance standards for use in general hospital settings, ensuring its reliability for clinical temperature monitoring.
Can this device be used in environments beyond hospitals, or is it specifically designed for hospital use?
While the RII Infrared Ear Thermometer (Model TH60N) was cleared under the General Hospital advisory committee classification, its design—rapid, non-contact temperature measurement—makes it suitable for any clinical setting requiring precise tympanic temperature readings, including outpatient clinics, emergency rooms, or other healthcare facilities where quick assessments are critical.
Properties & raw data
Show properties, registry sources and raw records
Sources (1)
- FDA 510(k) K101253