510(k) · Cleared
ClearedModification to the Oxyconalpha
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Erich Jaeger B.V. · BTY Calculator, Predicted Values, Pulmonary Function
Cleared on Jul 28, 1998 after a 200-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 4 later devices descend from it.
- Decided
- Jul 28, 1998
- Review
- 200 days
- Class
- Class II
- Product code
- BTY
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK980094 Modification to the OxyconalphaErich Jaeger B.V. · 1998
- Descendant · cites it directly · 3 of its ownK993641 Metalyzer, Model 2; Metalyzer, Model 3Cortex Biophysik GmbH · 2000
- Descendant · 2 generations on · 2 of its ownK090722 Shape-HF Cardiopulmonary Exercise Testing SystemShape Medical Systems, Inc. · 2009 · Recalled
- Descendant · cites it directly · 0 of its ownK150888 Shape-HF Cardiopulmonary Testing SystemShape Medical Systems, Inc. · 2016
- Descendant · 3 generations on · 0 of its ownK093080 Metaphor Metabolic MonitorTreymed, Inc. · 2010
Most influential descendants
Showing 4 of 4 · See all- K993641Metalyzer, Model 2; Metalyzer, Model 3Cortex Biophysik GmbH · 2000 · cites it directly3descendants
- K090722Shape-HF Cardiopulmonary Exercise Testing SystemShape Medical Systems, Inc. · 2009 · 2 generations on2descendants
- K150888Shape-HF Cardiopulmonary Testing SystemShape Medical Systems, Inc. · 2016 · cites it directly0descendants
- K093080Metaphor Metabolic MonitorTreymed, Inc. · 2010 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K980094 | Modification to the Oxyconalpha | Erich Jaeger B.V. | 1998 | — |
| +1 | K993641 | Metalyzer, Model 2; Metalyzer, Model 3 | Cortex Biophysik GmbH | 2000 | — |
| +2 | K090722 | Shape-HF Cardiopulmonary Exercise Testing System | Shape Medical Systems, Inc. | 2009 | 2 |
| +1 | K150888 | Shape-HF Cardiopulmonary Testing System | Shape Medical Systems, Inc. | 2016 | — |
| +3 | K093080 | Metaphor Metabolic Monitor | Treymed, Inc. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2016 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K993641 (Cortex Biophysik GmbH, 2000) has gone furthest, with 3 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.
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 OxyconAlpha is used as a predictive pulmonary function value calculator (Product code BTY). It i a software-driven, active medical device for investigational exercise measurements. It measures the human response to increasing workloads with emphasis on the gas exchange parameters. Measurements include ventilation, oxygen uptake, carbon dioxide production and derived parameters. It is the intention to determine on patients a cardiopulmonary limitation…
Read the full statement (205 words)
The OxyconAlpha is used as a predictive pulmonary function value calculator (Product code BTY). It i a software-driven, active medical device for investigational exercise measurements. It measures the human response to increasing workloads with emphasis on the gas exchange parameters. Measurements include ventilation, oxygen uptake, carbon dioxide production and derived parameters.
It is the intention to determine on patients a cardiopulmonary limitation and to test on sport athlets their training level. The different load levels for both groups can be generated over a bicycle ergometer or over a treadmill. The patient population is age 4 and older. The environment of use is indoor.
The OxyconAlpha interfaces to a testsubject via mouthpiece or a face mask. The OxyconAlpha interfaces to peripheral equipment and is therefore available in a variety of configurations from a standard controlled ergospirometry unit to a fully expandable laboratory system with blood pressure monitor, treadmill and ergometer. The OxyconAlpha interacts with the ECG signal (recorded by another device) only to the extent of extracting the patient's heart rate from the ECG signal. Other uses such as displaying or further analyzing the ECG waveforms are not included in the present submittal.
The device is not intended for use as a diagnostic pulmonary-function interpretation calculator.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K980094 · printed Nov 6, 2026
Cite this page
510(k) Report. “K980094: Modification to the Oxyconalpha.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K980094
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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