510(k) · Cleared
ClearedCPETWise Platform
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medibyt, Ltd. · BTY Calculator, Predicted Values, Pulmonary Function
Cleared on Aug 20, 2026 as substantially equivalent to K242809 (Medical Graphics Corporation, 2024) after a 206-day review. Its family tree reaches back 5 generations to 1995.
- Decided
- Aug 20, 2026
- Review
- 206 days
- Class
- Class II
- Product code
- BTY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K954140 (1995). 12 ancestors in all, the oldest K936108 (1995). No later device cites it as a predicate yet.
- Root · 5 generations backK954140 Masterscreen IosErich Jaeger GmbH & Co. KG · 1995
- 4 generations backK111053 Sentrysuite Product LineCarefusion Germany 234 GmbH · 2011
- 3 generations backK122699 Sentrysuite Product LineCarefusion Germany 234 GmbH · 2012
- 2 generations backK133925 Vyntus/ Sentrysuite Product LineCarefusion Germany 234 GmbH · 2014
- 1 generation backK242809 Ascent Cardiorespiratory Diagnostic SoftwareMedical Graphics Corporation · 2024
- This deviceK260242 CPETWise PlatformMedibyt, Ltd. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K954140 | Masterscreen Ios | Erich Jaeger GmbH & Co. KG | 1995 | — |
| −4 | K111053 | Sentrysuite Product Line | Carefusion Germany 234 GmbH | 2011 | — |
| −3 | K122699 | Sentrysuite Product Line | Carefusion Germany 234 GmbH | 2012 | — |
| −2 | K133925 | Vyntus/ Sentrysuite Product Line | Carefusion Germany 234 GmbH | 2014 | — |
| −1 | K242809 | Ascent Cardiorespiratory Diagnostic Software | Medical Graphics Corporation | 2024 | — |
| 0 (this device) | K260242 | CPETWise Platform | Medibyt, Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 2000 | 2 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2019 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in BTY? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new BTY device
- #1 K242809 Ascent Cardiorespiratory Diagnostic Softwarescore 12.1 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K242809 | Ascent Cardiorespiratory Diagnostic SoftwareSummary page 5…ulator, 21 CFR 868.1890 Regulations 21 CFR 868.1880 Product Code BTY, BZC Predicate Device K242809 Trade/Device Name: Ascent Cardiorespiratory Diagnostic Software Regulation Number: 21 CFR 868.1890 Regulation Name: Predictive Pu… | 2024 |
| † | K153654 | Sentry WEB SmartInterp | 2016 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 31 years and passes through 4 companies; a new generation was cleared every 1.8 years on median.
- None of the 12 ancestors has a recall.
How does its category compare?
All BTY devicesBTY Calculator, Predicted Values, Pulmonary Function: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · BTY
3in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · BTY
266in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BTY
2in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · BTY
5in 2024
MAUDE reports naming product code BTY, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 0 |
| 2008 | 3 | 104 | 0 | 0 |
| 2009 | 1 | — | 0 | 1 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 3 |
| 2012 | 3 | 139 | 0 | 2 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 1 | 1 |
| 2015 | 0 | — | 0 | 51 |
| 2016 | 1 | — | 0 | 24 |
| 2017 | 1 | — | 2 | 9 |
| 2018 | 0 | — | 0 | 5 |
| 2019 | 2 | — | 0 | 3 |
| 2020 | 1 | — | 0 | 3 |
| 2021 | 1 | — | 0 | 2 |
| 2022 | 1 | — | 0 | 2 |
| 2023 | 1 | — | 0 | 1 |
| 2024 | 3 | 266 | 0 | 5 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The CPETWise Platform is a software device that is intended to be used for already measured cardiopulmonary data for the analysis of cardiopulmonary testing (CPET) parameters and lung function (PFT) parameters, aiding in the diagnosis of related conditions.
The test results can be viewed online using a computer screen and printed after the test. The test results can be saved for further referral or report generation purposes.
The device can be utilized for patients aged 18 and older as long as they can cooperate in the CPET performance. The CPETWise platform is intended to be used in healthcare environments such as a hospital, a physician’s office, or similar settings.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K260242 · printed Nov 4, 2026
Cite this page
510(k) Report. “K260242: CPETWise Platform.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K260242
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026