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EasyOne Pro Respiratory Testing Device

FDA 510(k)

Class II (US FDA 510(k))

510(k) K120635

by Ndd Medizitechnik AG

Identifiers

510(k) Number
K120635 FDA 510(k)
FDA Product Code
BTY FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 868.1890 FDA 510(k)
Regulation Number
868.1890 FDA 510(k)
Advisory Committee
Anesthesiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The EasyOne Pro Respiratory Testing Device is a portable pulmonary function testing machine classified as a Calculator, Predicted Values, Pulmonary Function device under FDA regulation 868.1890. It performs spirometry, single-breath carbon monoxide diffusion (DLCO) testing, and multiple-breath nitrogen washout assessments to evaluate lung function parameters such as airflow, lung volumes, and gas exchange efficiency.

This device is intended for use in clinical settings, including general practice, clinics, and hospitals, and is designed for point-of-care diagnostics. Supplied as a reusable medical instrument, it requires proper calibration and maintenance to ensure accurate results. Authorized under FDA 510(k) clearance (K120635) with a traditional review process, it adheres to regulatory standards for respiratory diagnostic equipment. No specific sterility claims are stated, but standard infection control protocols apply for reusable devices.

Frequently asked questions

What types of lung function tests can the EasyOne Pro perform, and why is this important for clinical use?

The EasyOne Pro performs three key tests: spirometry (measuring airflow and lung volumes), single-breath carbon monoxide diffusion (DLCO, assessing gas exchange efficiency), and multiple-breath nitrogen washout (evaluating ventilation distribution). These tests collectively provide a comprehensive view of lung health, helping clinicians diagnose conditions like asthma, COPD, or restrictive lung diseases. The device’s ability to conduct these assessments in a portable, point-of-care format streamlines workflows in general practice, clinics, and hospitals.

Is the EasyOne Pro designed for single-use or reusable applications, and what maintenance is required?

The EasyOne Pro is supplied as a reusable medical instrument, meaning it is intended for repeated use across multiple patients. Since it is reusable, it must undergo proper calibration and maintenance to ensure accurate and reliable results. Standard infection control protocols, such as cleaning and sterilization between uses, are required to prevent cross-contamination, though the device itself does not claim specific sterility.

What regulatory pathway was followed for FDA clearance of the EasyOne Pro, and how does this affect its clinical use?

The EasyOne Pro received FDA clearance through the traditional 510(k) review process, specifically under the classification of a 'Calculator, Predicted Values, Pulmonary Function' device (product code BTY). This pathway confirms the device is substantially equivalent to a legally marketed predicate, ensuring it meets regulatory standards for safety and effectiveness in respiratory diagnostics. Clinically, this clearance allows for use in general practice, clinics, and hospitals for point-of-care diagnostics.

Are there multiple models or sizes available for the EasyOne Pro, and how might this impact user selection?

The EasyOne Pro is available in multiple configurations, as indicated by the diverse registration numbers (e.g., 3016218294, 3037873864). These likely correspond to different software versions, accessories, or regional adaptations rather than physical size variations. Users should verify compatibility with their workflow needs, as some models may include additional features like expanded DLCO analysis or specialized washout protocols, influencing clinical utility.

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: Portable Pulmonary Function Testing Machine - EasyOne Pro, EasyOne Spirometers and Complete Pulmonary Function Devices, Factsheet EasyOne Pro LAB - ndd Medical Technologies - PDF Catalogs ..., PDF EasyOne Pro

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Ndd Medizitechnik AG

Sources (1)

  • FDA 510(k) K120635 24 fields · synced Sep 19, 2026