EasyOne Sky Spirometer
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- EasyOne Sky EUDAMED
- Device Name
- Spirometry Family EUDAMED
- Model / Reference
- 2800-1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07640142190554 EUDAMED
- Basic UDI-DI
- 764014219SpirometerBS EUDAMED
- Direct Marketing DI
- 07640142190554 EUDAMED
- 510(k) Number
- K230178 FDA 510(k)
- FDA Product Code
- BZG FDA 510(k)
- EMDN Code
- Z12150180 SPIROMETRY INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 868.1840 FDA 510(k)
- Regulation Number
- 868.1840 FDA 510(k)
- Market of Registration
- Germany EUDAMED
- Advisory Committee
- Anesthesiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Clinical & Handling
Sterile
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
Yes
Incorporates Medicinal Product
No
The EasyOne Sky Spirometer is a diagnostic device classified as a spirometer, designed to measure lung function parameters such as forced expiratory volume (FEV₁) and forced vital capacity (FVC). It provides objective data for assessing respiratory conditions, including obstructive and restrictive lung diseases, by evaluating airflow and volume during forced exhalation.
This portable, single-use device is intended for use in clinical and home settings, adhering to FDA 510(k) and MDR regulatory standards. Supplied in sterile packaging, it requires no additional sterilization and is compatible with standard medical environments. The device is classified under device class II and is authorized for use in anesthesia and pulmonary function testing, with registration number 8030978 under regulation 868.1840.
Frequently asked questions
Is the EasyOne Sky Spirometer reusable or single-use, and what does this mean for my workflow?
The EasyOne Sky Spirometer is designed as a single-use device, meaning each unit is intended for one patient encounter only. This eliminates the need for sterilization between uses, simplifying workflows in both clinical and home settings. The sterile packaging ensures readiness for immediate use without additional preparation.
What key lung function parameters does the EasyOne Sky Spirometer measure, and how might this help in diagnosing respiratory conditions?
The device measures forced expiratory volume (FEV₁) and forced vital capacity (FVC), which are critical parameters for assessing airflow and lung volume during forced exhalation. These metrics help clinicians differentiate between obstructive (e.g., COPD, asthma) and restrictive (e.g., pulmonary fibrosis) lung diseases by providing objective data for diagnosis and treatment monitoring.
How is the EasyOne Sky Spirometer regulated, and what does this mean for its use in clinical environments?
The device is authorized under FDA 510(k) and MDR (Medical Device Regulation) standards, confirming its compliance with regulatory requirements for diagnostic spirometry. This classification under device class II ensures it meets stringent safety and performance criteria, making it suitable for use in anesthesia and pulmonary function testing environments as specified by its registration number (8030978).
What storage requirements apply to the EasyOne Sky Spirometer, and how should it be handled before use?
The device comes in sterile packaging, so no additional sterilization is required. It should be stored in a clean, dry environment away from direct sunlight or extreme temperatures to preserve its integrity. The packaging ensures readiness for immediate use, so no special handling (like wiping or disinfecting) is needed before patient use.
Is the EasyOne Sky Spirometer portable, and what settings is it designed for?
Yes, the EasyOne Sky Spirometer is portable, making it ideal for use in both clinical settings (hospitals, clinics) and home environments. Its compact design allows for easy transport and deployment, ensuring flexibility for testing patients in various locations without compromising accuracy or compliance.
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: Spirometry with Coach Buddy - Portable & PC spirometer - EasyOne Sky, EasyOne Spirometers and Complete Pulmonary Function Devices, EasyOne Sky Spirometer - MedicalRite, ndd Medical Technologies EasyOne Sky Spirometer | RT
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 | K230178 | Class II | Active |
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Manufacturer
- Manufacturer
- NDD Medizintechnik AG
Sources (2)
- FDA 510(k) K230178 24 fields · synced Sep 18, 2026
- EUDAMED 50869207-af66-4685-991b-be7b8908b051 61 fields · synced Jul 30, 2026