# K952417: Quest Exercise Stress System

- Pathway: 510(k) (Traditional)
- Applicant: Burdick, Inc.
- Decided: May 22, 1996 after 365 days
- Product code: DSI (Detector And Alarm, Arrhythmia)
- Device class: 2
- Regulation: 21 CFR 870.1025
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
7 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Quinton Q4500 Stress Test System: named in the summary without a submission number
- (no number) Burdick E350i Electrocardiograph: named in the summary without a submission number

## Most influential descendants
- K012206: Alternanas Processing System, CH 2000 Cardiac Diagnostic System, Heartwave Alternans Processing System (2001), 6 descendants of its own
- K013565: Cardiac Diagnostic System, Model CH2000 (2001), 3 descendants of its own
- K022149: Cardiac Diagnostic System, Model CH2000 (2002), 2 descendants of its own
- K050225: Heartwave II Cardiac Diagnostic System (2005), 1 descendant of its own
- K013564: Modification to Heartwave Alternans Processing System, Model Aps (2001), 1 descendant of its own

## Indications for use
Quest is designed to provide ECG information and data to qualified medical personnel for the purpose of assessing the patient's cardiac response to exercise. It is to be used in hospitals, clinics, or physician offices by a qualified and licensed physician, or by trained staff under the direct supervision of that physician. Stress-test or exercise electrocardiography is used a) when the diagnosis of coronary artery disease is suspected, b) to determine the physical performance characteristics of a patient, c) for post myocardial infarction assessment, or d) for cardiac rehabilitation. The test involves the recording of the electrocardiogram during dynamic or, occasionally, isometric exercise. The diagnostic value of exercise testing primarily concerns either ST segment depression present in myocardial ischemia, or elevation seen in infarcts (in comparison to P-Q segment as the isoelectic line). In addition it is important to consider the patient's blood pressure response and physical symptoms. Disease assessment is most prominent in, but not limited to, adult patients.

Source page: https://510kreport.com/device/K952417
Methodology: https://510kreport.com/methodology