Rii Infrared Ear Thermometer,
by Radiant Innovation Inc. Taiwan 510(k)
510(k) K102187 Product code FLL
Overview
The RII Infrared Ear Thermometer, Model TH01BN, is an electronic infrared thermometer classified as a Tympanic Thermometer (FDA Product Code: FLL). It measures body temperature by detecting natural thermal radiation from the tympanic membrane and adjacent auditory canal surfaces using a thermopile detector.
This single-use device is intended for home and general hospital use, as evidenced by its FDA 510(k) clearance under Special Review (K102187). Supplied sterile or non-sterile based on packaging, it requires no special storage conditions beyond those specified by the manufacturer. The device’s regulatory submission was reviewed by the Hospital Devices Subcommittee (HO) of the FDA’s Orthopaedic and Rehabilitation Devices Panel.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK102187 | Date10 Dec 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- Withdrawn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
Is the RII Infrared Ear Thermometer designed for reusable use in clinical settings, or is it meant to be used once and then discarded?
The RII Infrared Ear Thermometer (Model TH01BN) is explicitly labeled as a single-use device. This means it is intended for one-time use only, after which it should be discarded. The design and classification as a tympanic thermometer (FDA Product Code: FLL) align with single-use medical devices, ensuring hygiene and safety for both home and general hospital applications.
What storage conditions are required for the RII Infrared Ear Thermometer, and does it come in sterile packaging?
The RII Infrared Ear Thermometer does not require special storage conditions beyond what the manufacturer specifies. It is supplied in either sterile or non-sterile packaging, depending on the packaging variant. Since it is a single-use device, proper handling and storage per manufacturer instructions are recommended to maintain accuracy and reliability.
How does the RII Infrared Ear Thermometer measure body temperature, and what makes it suitable for both home and hospital use?
The device measures body temperature by detecting natural thermal radiation from the tympanic membrane and adjacent auditory canal surfaces using an infrared thermopile detector. This non-contact method ensures quick, accurate readings without physical contact, making it ideal for both home and general hospital use. Its FDA clearance under Special Review (K102187) under the General Hospital advisory category further supports its versatility.
What regulatory pathway was followed for the FDA clearance of the RII Infrared Ear Thermometer, and which committee reviewed the submission?
The RII Infrared Ear Thermometer received FDA clearance through a 510(k) premarket notification process, specifically under Special Review (K102187). The submission was reviewed by the Hospital Devices Subcommittee (HO) of the FDA’s Orthopaedic and Rehabilitation Devices Panel, confirming its compliance with regulatory standards for general hospital use.
Properties & raw data
Show properties, registry sources and raw records
Sources (1)
- FDA 510(k) K102187