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 Apr 12, 2019 after a 269-day review. The FDA summary names no predicate by number. 2 later devices descend from it.
- Decided
- Apr 12, 2019
- Review
- 269 days
- Class
- Class II
- Product code
- BTY
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 1 citing it directly.
- This deviceK181912 Ascent Cardiorespiratory Diagnostic SoftwareMedical Graphics Corporation · 2019
- Descendant · cites it directly · 1 of its ownK242809 Ascent Cardiorespiratory Diagnostic SoftwareMedical Graphics Corporation · 2024
- Descendant · 2 generations on · 0 of its ownK260242 CPETWise PlatformMedibyt, Ltd. · 2026
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K181912 | Ascent Cardiorespiratory Diagnostic Software | Medical Graphics Corporation | 2019 | — |
| +1 | K242809 | Ascent Cardiorespiratory Diagnostic Software | Medical Graphics Corporation | 2024 | — |
| +2 | K260242 | CPETWise Platform | Medibyt, Ltd. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
| 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?
The FDA summary names no predicate by number.
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K242809 | Ascent Cardiorespiratory Diagnostic Software | 2024 | 1 |
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?
- Of its descendants, K242809 (Medical Graphics Corporation, 2024) has gone furthest, with 1 descendant 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. 2019, 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 | — |
https://510kreport.com/device/K181912 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181912: 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/K181912
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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