510(k) · Cleared
ClearedOxycon Pro
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Erich Jaeger B.V. · BZC Calculator, Pulmonary Function Data
Cleared on Feb 22, 2000 after a 236-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 of the 10 devices in its family, counting itself, has a Class I recall. 9 later devices descend from it.
- Decided
- Feb 22, 2000
- Review
- 236 days
- Class
- Class II
- Product code
- BZC
- Recalls
- None
- Predicates
- 0
9 later devices descend from it, 1 citing it directly. 1 of the 10 devices in this family, counting this one, has a Class I recall.
- This deviceK992214 Oxycon ProErich Jaeger B.V. · 2000
- Descendant · cites it directly · 8 of its ownK133925 Vyntus/ Sentrysuite Product LineCarefusion Germany 234 GmbH · 2014
- Descendant · 2 generations on · 5 of its ownK150810 Vyntus / SentrySuite Product LineCarefusion Germany 234 GmbH · 2015 · Recalled (Class I)
- Descendant · 2 generations on · 1 of its ownK242809 Ascent Cardiorespiratory Diagnostic SoftwareMedical Graphics Corporation · 2024
- Descendant · 3 generations on · 1 of its ownK181524 Vyntus ONE with CART, Vyntus ONE PFT only with CART, Vyntus ONE with…Vyaire Medical, Inc. · 2018
- Descendant · 3 generations on · 0 of its ownK260242 CPETWise PlatformMedibyt, Ltd. · 2026
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K150810 Vyntus / SentrySuite Product Line2 generations on · 2015
Most influential descendants
Showing 5 of 9 · See all- K133925Vyntus/ Sentrysuite Product LineCarefusion Germany 234 GmbH · 2014 · cites it directly8descendants
- K150810Vyntus / SentrySuite Product LineCarefusion Germany 234 GmbH · 2015 · 2 generations on5descendants
- K242809Ascent Cardiorespiratory Diagnostic SoftwareMedical Graphics Corporation · 2024 · 2 generations on1descendant
- K181524Vyntus ONE with CART, Vyntus ONE PFT only with CART, Vyntus ONE with adjustable CART…Vyaire Medical, Inc. · 2018 · 3 generations on1descendant
- K260242CPETWise PlatformMedibyt, Ltd. · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K992214 | Oxycon Pro | Erich Jaeger B.V. | 2000 | — |
| +1 | K133925 | Vyntus/ Sentrysuite Product Line | Carefusion Germany 234 GmbH | 2014 | — |
| +2 | K150810 | Vyntus / SentrySuite Product Line | Carefusion Germany 234 GmbH | 2015 | Class I |
| +2 | K242809 | Ascent Cardiorespiratory Diagnostic Software | Medical Graphics Corporation | 2024 | — |
| +3 | K181524 | Vyntus ONE with CART, Vyntus ONE PFT only with CART, Vyntus ONE with… | Vyaire Medical, Inc. | 2018 | — |
| +3 | K260242 | CPETWise Platform | Medibyt, Ltd. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 1 | 1 |
| 2016 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2024 | 1 | 0 |
| 2026 | 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.
1 device in this family has a Class I recall. 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 BZC device
- #1 K240293 STSscore 9.8 · 7 generations · no Class I recall
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (9)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K133925 | Vyntus/ Sentrysuite Product Line | 2014 | 8 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K150810Vyntus / SentrySuite Product LineCarefusion Germany 234 GmbH · 2015 · 2 generations on · ◆ in the 2015 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K133925 (Carefusion Germany 234 GmbH, 2014) has gone furthest, with 8 descendants of its own.
How does its category compare?
All BZC devicesBZC Calculator, Pulmonary Function Data: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · BZC
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · BZC
Too few BZC 510(k)s in any year since 2007 to give a median.
Recalls per year · BZC
3in 2009
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · BZC
3in 2025
MAUDE reports naming product code BZC, 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 | 1 | — | 0 | 1 |
| 2008 | 0 | — | 0 | 3 |
| 2009 | 0 | — | 3 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 2 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 4 |
| 2017 | 1 | — | 0 | 1 |
| 2018 | 1 | — | 0 | 1 |
| 2019 | 2 | — | 0 | 7 |
| 2020 | 0 | — | 0 | 3 |
| 2021 | 0 | — | 0 | 5 |
| 2022 | 0 | — | 0 | 9 |
| 2023 | 0 | — | 0 | 8 |
| 2024 | 1 | — | 0 | 8 |
| 2025 | 0 | — | 0 | 3 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Oxycon Pro is a software-driven, medical device for exercise measurements, including ECG ST Segment Analysis and/or ECG Stress Analysis. It measures the human response to increasing workloads with emphasis on the gas exchange parameters. Measurements include ventilation, oxygen uptake, carbon dioxide excretion, heart rate and derived parameters. The results of the tests, including the ECG wave forms, can be viewed on the computer screen and can be…
Read the full statement (199 words)
The Oxycon Pro is a software-driven, medical device for exercise measurements, including ECG ST Segment Analysis and/or ECG Stress Analysis. It measures the human response to increasing workloads with emphasis on the gas exchange parameters. Measurements include ventilation, oxygen uptake, carbon dioxide excretion, heart rate and derived parameters. The results of the tests, including the ECG wave forms, can be viewed on the computer screen and can be printed during the test. The test results can be saved on the computer hard disk for further referral or report generation purposes.
The Oxycon Pro interfaces to a test subject via a mouthpiece or a face mask and ECG electrodes. The Oxycon Pro interfaces to a peripheral ergometer or treadmill. The patient population is 4 age and older.
The Oxycon Pro is capable of performing computerized ECG interpretation during resting condition.
The intended use locations are either in a physician office, hospital exercise rehabilitation facilities, or similar areas. [t is intended to be used by or on the order of a physician or similar qualified health care professional. This device is intended for use in the hospital environment, physician’s office, or similar settings. This device is not intended for home use.
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/K992214 · printed Nov 5, 2026
Cite this page
510(k) Report. “K992214: Oxycon Pro.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K992214
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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