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Sentiero, AuDX, AuDX PRO, Sentiero Desktop, AuDX PRO Flex, Sentiero Advanced, N…

FDA 510(k)

Class II (US FDA 510(k))

510(k) K213345

by PATH medical GmbH

Identifiers

510(k) Number
K213345 FDA 510(k)
FDA Product Code
EWO FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 874.1050 FDA 510(k)
Regulation Number
874.1050 FDA 510(k)
Advisory Committee
Ear, Nose, Throat FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Sentiero, AuDX, AuDX PRO, Sentiero Desktop, AuDX PRO Flex, Sentiero Advanced, and NavPRO ONE are audiometers, medical devices designed to measure hearing thresholds and auditory function. These devices evaluate hearing sensitivity across various frequencies and intensities, supporting the diagnosis and management of conditions such as hearing loss, tinnitus, and auditory dysfunction. They utilize automated testing protocols and adaptive algorithms to deliver precise and reproducible results for clinical assessment.

These audiometers are intended for use in clinical settings by qualified healthcare professionals, including audiologists and otolaryngologists. Supplied as reusable devices under FDA regulation 874.1050, they fall under Class II special controls and are classified under product code EWO. They hold FDA 510(k) clearance (K213345) for substantial equivalence in the Ear, Nose, and Throat specialty. Proper calibration and maintenance are required to ensure accuracy, and storage conditions must adhere to manufacturer guidelines. MRI compatibility varies by model and should be verified as needed.

Sentiero, AuDX, AuDX PRO, Sentiero Desktop, AuDX PRO Flex, Sentiero Advanced, NavPRO ONE

Frequently asked questions

What clinical conditions do the Sentiero audiometers assess?

The Sentiero audiometers evaluate hearing sensitivity across frequencies and intensities to diagnose and manage conditions like hearing loss, tinnitus, and auditory dysfunction. Their adaptive algorithms ensure precise, reproducible results for clinical assessments, supporting accurate diagnosis and treatment planning by audiologists and otolaryngologists.

Are these devices single-use or reusable, and how should they be maintained?

The Sentiero audiometers are reusable medical devices classified under FDA regulation 874.1050. Proper calibration and maintenance are essential to ensure accuracy, as outlined in the manufacturer’s guidelines. Regular servicing and adherence to calibration protocols are required to sustain performance standards.

What regulatory clearance do these audiometers hold, and under which product code?

The Sentiero audiometers hold FDA 510(k) clearance (K213345) for substantial equivalence in the Ear, Nose, and Throat specialty. They fall under product code EWO and are classified as Class II special controls devices, indicating they undergo rigorous review for safety and effectiveness.

How do I determine MRI compatibility for a specific Sentiero model?

MRI compatibility varies by model within the Sentiero series. Before use in an MRI environment, verify compatibility with the manufacturer’s documentation or contact PATH medical GmbH for model-specific guidance. Always follow safety protocols to avoid interference or damage to the device.

What storage conditions should be followed for these audiometers?

Storage conditions for the Sentiero audiometers must adhere to the manufacturer’s guidelines to preserve functionality and accuracy. This typically includes protecting the device from extreme temperatures, humidity, and physical damage. Follow the provided instructions to ensure optimal performance and longevity.

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: Sentiero, AuDX, AuDX PRO, Sentiero Desktop, AuDX PRO Flex, Sentiero ..., K213345 FDA 510 (k) - Sentiero | Path Medical GmbH, Sentiero, AuDX, AuDX PRO, Sentiero Desktop, AuDX PRO Flex, Sentiero ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
PATH medical GmbH

Sources (1)

  • FDA 510(k) K213345 24 fields · synced Oct 1, 2026