# K992214: Oxycon Pro

- Pathway: 510(k) (Traditional)
- Applicant: Erich Jaeger B.V.
- Decided: Feb 22, 2000 after 236 days
- Product code: BZC (Calculator, Pulmonary Function Data)
- Device class: 2
- Regulation: 21 CFR 868.1880
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
9 later devices descend from it; 1 cites it directly.
1 of 10 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K133925: Vyntus/ Sentrysuite Product Line (2014), 8 descendants of its own
- K150810: Vyntus / SentrySuite Product Line (2015), 5 descendants of its own
- K242809: Ascent Cardiorespiratory Diagnostic Software (2024), 1 descendant of its own
- K181524: Vyntus ONE with CART, Vyntus ONE PFT only with CART, Vyntus ONE with adjustable CART, Vyntus ONE PFT only with adjustable CART (2018), 1 descendant of its own
- K260242: CPETWise Platform (2026), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K992214
Methodology: https://510kreport.com/methodology