Temple Touch Pro (TTP) Non-invasive Temperature Monitoring System
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K150160 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 Temple Touch Pro (TTP) is a non-invasive temperature monitoring system designed for continuous, accurate measurement of core body temperature via the temporal artery in the forehead. It utilises advanced thermal sensing technology to provide real-time data without the need for invasive procedures, making it suitable for patient populations where traditional methods may be impractical or unsafe.
This system is intended for use in general hospital settings, offering a reusable design with FDA 510(k) clearance under the Traditional pathway, as well as compliance with the Medical Device Directive (MDD) and Medical Device Regulation (MDR). Supplied as a reusable device, it requires proper sterilisation and maintenance per manufacturer guidelines, ensuring reliability for prolonged clinical use. No MRI safety information is specified, and its regulatory status is explicitly tied to the stated authorisations.
Frequently asked questions
How does the Temple Touch Pro differ from traditional invasive temperature monitoring methods in terms of patient suitability?
The Temple Touch Pro is designed as a non-invasive system that measures core body temperature via the temporal artery in the forehead, eliminating the need for invasive procedures like rectal or bladder probes. This makes it particularly suitable for patients—such as infants, elderly individuals, or those with sensitive skin or coagulation disorders—where traditional methods may be impractical, unsafe, or uncomfortable. Its reusable design also supports prolonged clinical use in general hospital settings.
Is the Temple Touch Pro single-use or reusable, and what maintenance is required?
The Temple Touch Pro is a reusable device, which means it can be used across multiple patients with proper sterilization and maintenance following Medisim’s guidelines. Since it’s not single-use, hospitals must adhere to cleaning and sterilization protocols to ensure accuracy, reliability, and infection control between uses. The manufacturer emphasizes this requirement to maintain performance for continuous clinical use.
What regulatory pathways has the Temple Touch Pro gone through, and how does that affect its use in hospitals?
The Temple Touch Pro has received FDA clearance under the Traditional 510(k) pathway, as well as compliance with the Medical Device Directive (MDD) and Medical Device Regulation (MDR). This means it has been evaluated for substantial equivalence to a predicate device and meets EU safety and performance standards. Hospitals can rely on these authorizations to ensure the device meets regulatory requirements for use in general hospital settings, though local compliance with sterilization and maintenance remains the user’s responsibility.
Can the Temple Touch Pro be used in all hospital departments, or are there specific limitations?
The Temple Touch Pro is explicitly intended for general hospital settings, as indicated by its FDA clearance under the General Hospital advisory committee category. While it’s designed for continuous, non-invasive temperature monitoring, there are no explicit restrictions mentioned beyond its intended use. However, hospitals should confirm compatibility with their specific patient populations and workflows, particularly for high-risk or specialized care units, as the device’s suitability may vary based on clinical context.
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
MDD
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K150160 | Class II | Active |
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Manufacturer
- Manufacturer
- Medisim, Ltd.
Sources (2)
- FDA 510(k) K150160 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026