Non-Contact Infrared Thermometer
by Jinxinbao Electronic Co., Ltd
510(k) K130231
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK130231 | Date15 Oct 2013 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- FLL
- FDA applicant
- Jinxinbao Electronic Co.,Ltd
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.2910
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Non-Contact Infrared Thermometer is a medical device classified as a non-invasive temperature measurement instrument (FDA Product Code: FLL). It employs infrared technology to measure body temperature without physical contact, providing rapid and accurate readings by detecting thermal radiation emitted from the temporal artery region.
This device is intended for use in general hospital settings and is supplied as a single-use or reusable instrument, depending on manufacturer specifications. It has received FDA 510(k) clearance under an abbreviated review process, ensuring compliance with regulatory standards. The device is designed for non-invasive use and does not require sterilization, though proper cleaning and maintenance protocols must be followed as per manufacturer guidelines.
Other devices from Jinxinbao Electronic Co., Ltd
Questions
AI-generated answers, 19 Sep 2026
How does the Non-Contact Infrared Thermometer work, and what part of the body does it measure temperature from?
The Non-Contact Infrared Thermometer uses infrared technology to detect thermal radiation emitted from the body. It measures temperature by focusing on the temporal artery region—located on the forehead—without requiring physical contact, providing a rapid and non-invasive reading.
Is this device meant for single-use or reusable applications, and what cleaning or maintenance is required?
The device can be supplied as either single-use or reusable, depending on the manufacturer’s specifications. While it does not require sterilization, proper cleaning and maintenance must still be followed as outlined in the manufacturer’s guidelines to ensure accuracy and hygiene.
What type of regulatory clearance does this thermometer have, and what does that mean for its use in hospitals?
The Non-Contact Infrared Thermometer received FDA 510(k) clearance under an abbreviated review process, confirming it is substantially equivalent to a legally marketed device. This clearance ensures compliance with U.S. regulatory standards, allowing its use in general hospital settings for non-invasive temperature measurement.
Are there different models or sizes available for this thermometer, and if so, how would I know which one to choose?
The provided data does not specify distinct models or sizes for this thermometer. Since it is classified under FDA Product Code FLL (general hospital use), compatibility would depend on manufacturer specifications. For precise selection, consult the manufacturer’s documentation or sales team to confirm compatibility with your facility’s needs.