RII Smart IR Thermometer

510(k) Number

K163601 ↗

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

• Multi-function Infrared Thermometer

  Class IIa

  CE/MDR TW24/00000261 Active Valid to Mar 2029

• Laboratoire Marque Verte

  Class IIa

  CE/MDD

• Infared Ear Thermometer, Model TH8 Series

  Class II

  FDA 510(k) K011059 Active Cleared 17 Sep 2001

• RII Infrared Ear Thermometer, Model TH01BN

  Class II

  FDA 510(k) K070976 Active Cleared 20 Apr 2007

• Infrared Ear Thermometer, Models TH88 Series

  Class II

  FDA 510(k) K020504 Active Cleared 28 Feb 2002

• RII Infrared Ear Thermometer, Model TH60N

  Class II

  FDA 510(k) K101253 Active Cleared 29 Jun 2010

See all devices from Radiant Innovation Inc. →

• What types of environments or settings is the RII Smart IR Thermometer intended for use in, and how does its non-contact design benefit those settings?

  The RII Smart IR Thermometer is designed for general hospital use, as indicated by its FDA clearance under product code FLL. Its non-contact infrared technology allows for rapid, precise temperature measurements without physical contact, which is particularly useful in clinical settings where minimizing patient contact is important—such as during outbreaks, for pediatric patients, or when assessing surface temperatures of medical equipment or environments (e.g., incubators, rooms). This reduces the risk of cross-contamination and streamlines workflows.

• Is the RII Smart IR Thermometer intended for single-use or reusable applications, and what cleaning guidelines should be followed if it’s reused?

  The RII Smart IR Thermometer is designed for both single-use and reusable settings, depending on facility protocols. While the device itself does not specify sterility requirements beyond standard manufacturer cleaning protocols, reusable units should be cleaned and disinfected according to the manufacturer’s guidelines to maintain accuracy and hygiene. Always follow Radiant Innovation Inc.’s instructions to ensure proper maintenance and functionality, especially if used across multiple patients or environments.

• How does the RII Smart IR Thermometer’s FDA clearance (K163601) relate to its intended use, and what does ‘substantially equivalent’ mean in this context?

  The RII Smart IR Thermometer received FDA clearance under the 510(k) pathway (K163601) with a decision labeled as ‘substantially equivalent’ (SESE) to a predicate device. This means the FDA determined that the device has the same intended purpose as a previously cleared infrared thermometer and does not present new risks that outweigh its benefits. The clearance confirms it meets regulatory standards for safety and effectiveness as a non-contact infrared thermometer for general hospital use, including body and ambient temperature applications.

• What size or model variations are available for the RII Smart IR Thermometer, and how might this affect its suitability for different clinical tasks?

  The provided data does not specify individual size or model variations for the RII Smart IR Thermometer, as the description focuses on its core design as a standalone, non-contact infrared device. However, its general-purpose clearance (product code FLL) suggests it is likely designed for versatility in clinical settings, such as measuring body temperatures (e.g., forehead, ear canal proxies) or environmental surfaces. For precise sizing or model-specific features, refer to Radiant Innovation Inc.’s technical documentation or contact their support team.