Digital Thermometer, Models MT-XX8 and MT-XX9
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K041516 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 Digital Thermometer, Models MT-XX8 and MT-XX9, is a medical device classified as a thermometer designed for measuring body temperature. It provides rapid, accurate digital readings, facilitating clinical assessments in various healthcare settings.
These models are intended for single-use or reusable applications in general hospital environments, as indicated by their advisory committee classification. Supplied in sterile or non-sterile packaging depending on the model, they are regulated under FDA 510(k) clearance and EU MDR compliance. The devices are non-magnetic and suitable for general use without MRI safety restrictions.
Frequently asked questions
Are these digital thermometers designed for single-use or reusable applications, and how do I know which model I’m getting?
The MT-XX8 and MT-XX9 models are both intended for single-use or reusable applications in general hospital settings. The key difference lies in packaging: the MT-XX8 is supplied in sterile packaging, while the MT-XX9 is non-sterile. Always check the packaging label to confirm which model you’re using, as this determines whether the device is pre-sterilized or requires sterilization before reuse.
Can I use these thermometers in an MRI environment, and if not, why?
No, these thermometers are not MRI-safe—they are explicitly labeled as non-magnetic. This means they should not be used in or near MRI machines, as the magnetic fields could interfere with the device or pose safety risks. The manufacturer’s design prioritizes general clinical use rather than compatibility with MRI environments.
What regulatory pathways have these thermometers followed, and how does that affect their use?
These thermometers are cleared under FDA 510(k) (K041516) and comply with EU MDR, meaning they meet U.S. and European regulatory standards for safety and performance. The 510(k) clearance confirms they are substantially equivalent to a predicate device, while MDR compliance ensures they align with current EU medical device regulations. Clinicians or buyers should confirm local regulatory requirements before use, but these clearances validate their suitability for general hospital temperature measurements.
How do I determine which model (MT-XX8 or MT-XX9) is right for my facility’s needs?
Choose the MT-XX8 if you require sterile, single-use thermometers for procedures where contamination risk is a concern, such as in operating rooms or sterile patient care areas. Opt for the MT-XX9 if you prefer a non-sterile, reusable option for general clinical use, such as outpatient exams or non-invasive settings, where sterilization between uses is feasible. The decision depends on your facility’s infection control protocols and workflow.
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 | K041516 | Class II | Active |
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Manufacturer
- Manufacturer
- Vega Technologies Inc.
- FDA Applicant
- Vega Technologies, Inc.
Sources (2)
- FDA 510(k) K041516 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026