Infared Ear Thermometer, Model TH8 Series
by Radiant Innovation Inc. Taiwan 510(k)
510(k) K011059 Product code FLL
Overview
The Infrared Ear Thermometer, Model TH8 Series, is a clinical electronic thermometer designed to measure body temperature via infrared radiation detected in the ear canal. It falls under the classification of a non-contact, infrared-based temperature monitoring device, providing rapid readings within one second.
This device is intended for single-use or reusable clinical settings, including general hospital environments, and is supplied sterile or non-sterile as specified by the manufacturer. The Model TH8 Series operates under FDA 510(k) clearance (K011059) with a product code FLL, adhering to regulatory standards for electronic clinical thermometers. Storage and handling instructions are detailed in the manufacturer’s manual, ensuring proper functionality and accuracy.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK011059 | Date17 Sep 2001 | 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- Withdrawn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 quickly does the Infrared Ear Thermometer (Model TH8 Series) provide a temperature reading, and why is this feature important in clinical settings?
The Infrared Ear Thermometer (Model TH8 Series) delivers a temperature reading within one second. This rapid response time is critical in clinical settings because it minimizes patient discomfort and allows for quicker clinical decision-making, which is especially valuable in fast-paced environments like emergency rooms or general hospital wards.
Can the Infrared Ear Thermometer (Model TH8 Series) be used repeatedly in a clinical setting, or is it designed for single-use only?
The device is designed for both single-use and reusable applications in clinical settings, including general hospitals. The manufacturer specifies whether each unit is supplied sterile or non-sterile, allowing flexibility depending on the procedure’s requirements and infection control protocols.
What regulatory pathway was followed for the FDA clearance of the Infrared Ear Thermometer (Model TH8 Series), and what does this mean for its use in hospitals?
The device received FDA clearance through a 510(k) submission (K011059) under the Traditional 510(k) Review pathway, with a classification of Substantially Equivalent (SESE) to a predicate device. This means the FDA determined it meets the same performance standards as existing infrared ear thermometers, ensuring its safety and effectiveness for use in general hospital environments as intended.
How should the Infrared Ear Thermometer (Model TH8 Series) be stored to maintain accuracy and functionality over time?
Storage instructions are provided in the manufacturer’s manual, which must be followed to preserve the device’s accuracy and functionality. While specifics aren’t detailed here, proper storage typically involves protecting the device from extreme temperatures, humidity, and physical damage—common practices for electronic medical devices—to ensure reliable performance when needed.
Properties & raw data
Show properties, registry sources and raw records
Sources (1)
- FDA 510(k) K011059