510(k) · Cleared
ClearedAscent Cardiorespiratory Diagnostic Software
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medical Graphics Corporation · BTY Calculator, Predicted Values, Pulmonary Function
Cleared on Oct 17, 2024 as substantially equivalent to K181912 (Medical Graphics Corporation, 2019) and 1 other predicate after a 30-day review. Its family tree reaches back 4 generations to 1995. 1 later device descends from it.
- Decided
- Oct 17, 2024
- Review
- 30 days
- Class
- Class II
- Product code
- BTY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K954140 (1995). 11 ancestors in all, the oldest K936108 (1995). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK954140 Masterscreen IosErich Jaeger GmbH & Co. KG · 1995
- 3 generations backK111053 Sentrysuite Product LineCarefusion Germany 234 GmbH · 2011
- 2 generations backK122699 Sentrysuite Product LineCarefusion Germany 234 GmbH · 2012
- 1 generation backK133925 Vyntus/ Sentrysuite Product LineCarefusion Germany 234 GmbH · 2014
- This deviceK242809 Ascent Cardiorespiratory Diagnostic SoftwareMedical Graphics Corporation · 2024
- Descendant · cites it directly · 0 of its ownK260242 CPETWise PlatformMedibyt, Ltd. · 2026
Most influential descendants
Showing 1 of 1 · See all- K260242CPETWise PlatformMedibyt, Ltd. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K954140 | Masterscreen Ios | Erich Jaeger GmbH & Co. KG | 1995 | — |
| −3 | K111053 | Sentrysuite Product Line | Carefusion Germany 234 GmbH | 2011 | — |
| −2 | K122699 | Sentrysuite Product Line | Carefusion Germany 234 GmbH | 2012 | — |
| −1 | K133925 | Vyntus/ Sentrysuite Product Line | Carefusion Germany 234 GmbH | 2014 | — |
| 0 (this device) | K242809 | Ascent Cardiorespiratory Diagnostic Software | Medical Graphics Corporation | 2024 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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 K260242 CPETWise Platformscore 13.1 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K181912 | Ascent Cardiorespiratory Diagnostic SoftwareSummary page 5…sification Names: Calculator, Predicted Values, Pulmonary Function, 21 CFR 868.1890, BTY Pulmonary Function Data Calculator, 21 CFR 868.1880, BZC Predicate Devices: K181912, Ascent™ Cardiorespiratory Diagnostic Software K133925, Vyntus SentrySuite Product Line Intended Use/Indi… | 2019 |
| * | K133925 | Vyntus/ Sentrysuite Product LineSummary page 5….1890, BTY Pulmonary Function Data Calculator, 21 CFR 868.1880, BZC Predicate Devices: K181912, Ascent™ Cardiorespiratory Diagnostic Software K133925, Vyntus SentrySuite Product Line Intended Use/Indications for Use: Ascent Cardiorespiratory Diagnostic Software is intended to b… | 2014 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K260242 | CPETWise Platform | 2026 | 0 |
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 29 years and passes through 3 companies; a new generation was cleared every 10.2 years on median.
- None of the 11 ancestors has a recall.
- Of its descendants, K260242 (Medibyt, Ltd., 2026) has gone furthest, with 0 descendants of its own.
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. 2024, 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?
Ascent Cardiorespiratory Diagnostic Software is intended to be used for measurements, data collection and analysis of lung function (PFT) parameters, and cardiopulmonary testing (CPET) parameters, aiding in the diagnosis of related conditions. All the measurements are performed via a mouthpiece or a mask. The results of the test can be viewed on-line with the help of a computer screen and can be printed after the test. The test results can be saved for…
Read the full statement (167 words)
Ascent Cardiorespiratory Diagnostic Software is intended to be used for measurements, data collection and analysis of lung function (PFT) parameters, and cardiopulmonary testing (CPET) parameters, aiding in the diagnosis of related conditions.
All the measurements are performed via a mouthpiece or a mask.
The results of the test can be viewed on-line with the help of a computer screen and can be printed after the test. The test results can be saved for further referral or report generation purposes.
For use of the Bronchial Challenge option, the medical director of the laboratory, physician, or person appropriately trained to treat acute bronchoconstriction, including appropriate use of resuscitation equipment, must be close enough to respond quickly to an emergency.
The product can be utilized for patients from 4 years old and older as long as they can cooperate in the performance -- no special limit to patient's sex or height.
Measurements will be performed under the direction of a physician in a hospital environment, physician's office or similar settings.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K242809 · printed Nov 6, 2026
Cite this page
510(k) Report. “K242809: Ascent Cardiorespiratory Diagnostic Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K242809
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026