Non-Contact Clinical Thermometer
by Radiant Innovation Inc. Taiwan 510(k)
510(k) K121428 Product code FLL
Overview
The Non-Contact Clinical Thermometer is an infrared thermometer classified under the device type for non-invasive temperature measurement. It employs a thermopile detector to measure human body temperature without physical contact, enabling rapid and hygienic readings from the forehead center in individuals of all ages.
This device is intended for intermittent use in clinical settings and is supplied as a reusable instrument. It has received FDA 510(k) clearance under the product code FLL, with no third-party review. The thermometer operates without MRI compatibility concerns and requires proper storage to maintain accuracy and functionality.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK121428 | Date17 Jul 2012 | 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- Withdrawn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
With more than 20 years in the infrared field, our RD, QA, Manufacture Team continues to deepen its professional expertise for developing three product lines including Medical Infrared Thermometer, Industrial Non-contact Infrared Thermometer, and CO2 Monitor.
Other devices from Radiant Innovation Inc.
Questions
How does the Non-Contact Clinical Thermometer differ from traditional contact thermometers in terms of hygiene and speed of use?
The Non-Contact Clinical Thermometer measures body temperature without physical contact, eliminating the need for probes or mouthpieces that can harbor pathogens. This design reduces cross-contamination risks in clinical settings. Additionally, it provides rapid readings in seconds by detecting infrared energy from the forehead’s center, making it significantly faster than traditional contact thermometers, which often require several minutes to stabilize.
Is the Non-Contact Clinical Thermometer designed for single-use or reusable applications, and what does this mean for maintenance?
The device is explicitly supplied as a reusable instrument, meaning it is intended for repeated use across multiple patients. Since it is reusable, proper cleaning and maintenance protocols must be followed to ensure accuracy and functionality. The manufacturer’s instructions should outline the recommended cleaning procedures to prevent damage to the infrared sensor or other components.
What storage conditions are necessary to ensure the Non-Contact Clinical Thermometer remains accurate and functional over time?
While the device data does not specify exact storage conditions, the mention of 'proper storage' to maintain accuracy and functionality implies it should be kept in a clean, dry environment away from extreme temperatures or direct sunlight. Avoiding exposure to moisture, dust, or physical impacts is critical, as these factors could compromise the thermopile detector or overall performance.
What is the intended clinical setting for this thermometer, and does it have any special considerations for use?
The device is classified under the product code FLL, which aligns with its intended use in general hospital settings for non-invasive temperature measurement. It is designed for intermittent clinical use, meaning it is not meant for continuous monitoring but rather for periodic checks. Additionally, the device is noted to have no MRI compatibility concerns, so it can be safely used in areas where MRI machines are present without interference.
Properties & raw data
Show properties, registry sources and raw records
Sources (1)
- FDA 510(k) K121428