SpiroSphere, SpiroSphereECG, CardioSphere
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K223629 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 SpiroSphere, SpiroSphereECG, and CardioSphere are Pulmonary Function Calculators designed to predict and analyze spirometry values. These devices assess lung function by generating predicted reference values for forced expiratory volume (FEV₁), forced vital capacity (FVC), and other spirometry metrics, aiding in the diagnosis and monitoring of respiratory conditions such as asthma and chronic obstructive pulmonary disease (COPD).
These devices are intended for use in clinical and research settings, including anesthesiology, and are supplied as software-based tools. They are classified under Device Class II (FDA) and comply with MDR (Medical Device Regulation) standards. The SpiroSphere series operates as standalone calculators, requiring no sterilization or single-use considerations, and are compatible with standard spirometry equipment. Authorized under FDA 510(k) clearance (K223629) and EU MDR, they are intended for predictive analysis only and do not replace clinical judgment.
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 | K223629 | Class II | Active |
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Manufacturer
- Manufacturer
- eResearchTechnology GmbH
Sources (2)
- FDA 510(k) K223629 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 18, 2026