CPETWise Platform
FDA 510(k) K260242 · Medibyt , Ltd.
510(k) numberK260242
Submission
- Device name
- CPETWise Platform
- Applicant
- Medibyt , Ltd.
Yakum, IL - Received
- January 26, 2026
- Decision date
- August 20, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
Device classification
- Product code
- BTY – Calculator, Predicted Values, Pulmonary Function
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.1890
- Specialty
- Anesthesiology
Other 510(k)s with product code BTY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K242809 | Ascent Cardiorespiratory Diagnostic SoftwareBTY · Traditional | Medical Graphics Corporation | 10/17/2024SE |
| K223629 | SpiroSphere, SpiroSphereECG, CardioSphereBTY · Traditional | Eresearchtechnology GmbH | 05/28/2024SE |
| K231561 | Pulmonary Function Tester, Model: A9BTY · Traditional | Guangzhou Homesun Medical Technology Co., Ltd. | 02/21/2024SE |
| K222982 | Virtus Metabolic MonitorBTY · Traditional | Virtus Technology Aps | 06/23/2023SE |
| K221030 | Model 9100 PFT/DICOBTY · Traditional | Vitalograph Ireland, Ltd. | 07/15/2022SE |
| K202754 | MasterScope, MasterScope CT, MasterScope ECG, MasterScope WSSUBTY · Traditional | Eresearchtechnology GmbH | 01/28/2021SE |
| K190800 | Cosmed Q-NRG / Q-NRG+ Portable Metabolic MonitorsBTY · Traditional | Cosmed Srl | 02/06/2020SE |
| K181912 | Ascent Cardiorespiratory Diagnostic SoftwareBTY · Traditional | Medical Graphics Corporation | 04/12/2019SE |
| K173937 | SpiroSphereBTY · Traditional | Eresearchtechnology GmbH | 02/15/2019SE |
| K161534 | EasyOne Pro Respiratory Analysis SystemBTY · Traditional | Ndd Medizintechnik AG | 02/22/2017SE |
Questions and answers
When was CPETWise Platform cleared by the FDA?
CPETWise Platform (K260242) received a 510(k) decision of Substantially Equivalent on August 20, 2026, 206 days after the submission was received.
What is the product code of K260242?
The FDA product code is BTY – Calculator, Predicted Values, Pulmonary Function, a Class II (moderate risk) device regulated under 21 CFR 868.1890.