Infrared Ear Themometer, Models Dx6603, Dx66390
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K051251 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 Infrared Ear Thermometer, Models DX6603 and DX66390, is a Clinical Electronic Thermometer (21 CFR 880.2910) designed to measure core body temperature by detecting infrared energy emitted from the auditory canal. It converts thermal radiation into a digital temperature reading, providing rapid and non-invasive temperature assessment for clinical or home use.
This handheld device is intended for single-use or reusable applications, depending on manufacturer guidelines, and operates under FDA 510(k) clearance (K051251) and MDR compliance. Supplied sterile or non-sterile as specified, it requires no special storage conditions beyond protection from physical damage and extreme temperatures. The device is classified as Class II under 21 CFR 880.2910 and is regulated for use in general hospital settings.
Frequently asked questions
What are the key differences between the DX6603 and DX66390 models of this infrared ear thermometer?
The provided data does not specify any technical, functional, or design differences between the DX6603 and DX66390 models beyond their distinct model numbers. Both are classified as infrared ear thermometers under 21 CFR 880.2910 and share the same regulatory pathway (FDA 510(k) clearance K051251). To determine specific distinctions, such as accuracy, features, or intended use variations, you would need to consult the manufacturer’s documentation or contact Shenzhen Dongdixin Technology Co., Ltd. directly.
Can this thermometer be used in both clinical and home settings, and how is it supplied?
Yes, the device is designed for clinical or home use as a non-invasive method to measure core body temperature via infrared energy detection in the auditory canal. It is supplied either sterile or non-sterile, depending on the specific order or packaging. The manufacturer’s guidelines determine whether it is intended for single-use or reusable applications, though no additional details on reprocessing protocols are provided in the data.
What storage requirements does this thermometer have, and how should it be protected?
The device requires no special storage conditions beyond protection from physical damage and extreme temperatures. It is a handheld unit, so it should be stored in a dry, stable environment away from direct sunlight or moisture. Since it is classified under 21 CFR 880.2910 for general hospital use, clinical settings should follow standard device storage protocols to maintain functionality and accuracy.
How is the regulatory status of this thermometer defined, and what does the FDA 510(k) clearance indicate?
The thermometer holds FDA 510(k) clearance (K051251) under the Traditional 510(k) Review pathway, classified as Substantially Equivalent (SESE) to a predicate device. This clearance indicates that the device meets FDA requirements for safety and effectiveness as determined by the Hospital Orthopedics (HO) Advisory Committee. The MDR (Medical Device Regulation) compliance also applies, aligning with EU regulatory standards. The clearance does not specify clinical indications but confirms the device’s conformity to regulatory expectations for infrared ear thermometers.
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. Sources consulted: Infrared Ear Themometer, Models Dx6603, Dx66390, PDF K051251 - Infrared Ear Themometer, Models Dx6603, Dx66390, 510(k) K051251 — INFRARED EAR THEMOMETER, MODELS DX6603, DX66390, fda.innolitics.com, Device Listing 1545403527 - FDA.report
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 | K051251 | Class II | Active |
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Manufacturer
- Manufacturer
- Shenzhen Dongdixin Technology Co., Ltd.
Sources (2)
- FDA 510(k) K051251 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026