BTY
- Product code
- BTY
- Device name
- Calculator, Predicted Values, Pulmonary Function
- Device class
- Class 2
- 21 CFR
- 21 CFR 868.1890
- Medical specialty
- Anesthesiology
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 4
- Summaries archived here
- 3 (direct download)
- 510(k) clearances (all years, FDA)
- 64 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (4)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K260242 | 2026-08-20 | Medibyt , Ltd. | CPETWise Platform | FDA |
| K242809 | 2024-10-17 | Medical Graphics Corporation | Ascent Cardiorespiratory Diagnostic Software | |
| K223629 | 2024-05-28 | Eresearchtechnology GmbH | SpiroSphere, SpiroSphereECG, CardioSphere | |
| K231561 | 2024-02-21 | Guangzhou Homesun Medical Technology C… | Pulmonary Function Tester, Model: A9 |
Official FDA classification page: BTY
Classification and pathway per current FDA publications. Data from openFDA (CC0).