Non-Contact Infrared Thermometer
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K131243 FDA 510(k)
- FDA Product Code
- FLL FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 880.2910 FDA 510(k)
- Regulation Number
- 880.2910 FDA 510(k)
- Advisory Committee
- General Hospital FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Non-Contact Infrared Thermometer is a diagnostic device classified as a non-invasive temperature measurement instrument under the FDA’s General Hospital category. It measures body temperature by detecting infrared radiation emitted from the skin without physical contact, providing rapid readings for clinical screening.
This device is supplied as a single-use or reusable instrument, depending on manufacturer specifications, and is intended for use in hospital, clinic, or home settings. It is not MRI-safe and requires proper calibration and storage per manufacturer instructions. Authorised under FDA 510K clearance (K131243) and MDR compliance, it adheres to regulatory standards for non-invasive temperature monitoring.
Frequently asked questions
How does the Non-Contact Infrared Thermometer work in clinical settings, and what types of environments is it designed for?
The Non-Contact Infrared Thermometer measures body temperature by detecting infrared radiation emitted from the skin without direct contact, enabling quick and non-invasive readings. It is designed for use in hospital, clinic, or home settings, making it versatile for various clinical screening applications where rapid temperature assessment is needed.
Is the Non-Contact Infrared Thermometer intended for single-use or reusable applications, and what should I consider when deciding?
The device can be supplied as either single-use or reusable, depending on the manufacturer’s specifications. If choosing a reusable model, ensure proper cleaning, sterilization, and maintenance protocols are followed to prevent cross-contamination and maintain accuracy. Single-use models eliminate these concerns but may require more frequent replacement.
What storage and handling instructions should I follow to ensure the device remains accurate and functional?
The device requires proper calibration and storage as instructed by the manufacturer. It should be stored in a clean, dry environment away from direct sunlight or extreme temperatures to prevent damage. Avoid exposure to moisture or magnetic fields, and ensure it is not used near MRI equipment, as it is not MRI-safe.
What regulatory approvals does the Non-Contact Infrared Thermometer hold, and how does this affect its use?
The device holds FDA 510(k) clearance (K131243) under the General Hospital category and complies with the EU’s Medical Device Regulation (MDR). These approvals confirm it meets U.S. and EU standards for non-invasive temperature monitoring, ensuring its safety and performance for clinical use in authorized regions.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K131243 | Class II | Active |
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Manufacturer
- Manufacturer
- Shenzhen Jumper Medical Equipment Co., Ltd.
Sources (2)
- FDA 510(k) K131243 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 19, 2026