510(k) · Cleared
ClearedQuest Exercise Stress System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Burdick, Inc. · DSI Detector And Alarm, Arrhythmia
Cleared on May 22, 1996 after a 365-day review. The FDA summary names its predicate without a number. 7 later devices descend from it.
- Decided
- May 22, 1996
- Review
- 365 days
- Class
- Class II
- Product code
- DSI
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 1 citing it directly.
- This deviceK952417 Quest Exercise Stress SystemBurdick, Inc. · 1996
- Descendant · cites it directly · 6 of its ownK012206 Alternanas Processing System, CH 2000 Cardiac Diagnostic System…Cambridge Heart, Inc. · 2001
- Descendant · 2 generations on · 3 of its ownK013565 Cardiac Diagnostic System, Model CH2000Cambridge Heart, Inc. · 2001
- Descendant · 3 generations on · 2 of its ownK022149 Cardiac Diagnostic System, Model CH2000Cambridge Heart, Inc. · 2002
- Descendant · 4 generations on · 1 of its ownK050225 Heartwave II Cardiac Diagnostic SystemCambridge Heart, Inc. · 2005
- Descendant · 2 generations on · 1 of its ownK013564 Modification to Heartwave Alternans Processing System, Model ApsCambridge Heart, Inc. · 2001
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K012206Alternanas Processing System, CH 2000 Cardiac Diagnostic System, Heartwave Alternans…Cambridge Heart, Inc. · 2001 · cites it directly6descendants
- K013565Cardiac Diagnostic System, Model CH2000Cambridge Heart, Inc. · 2001 · 2 generations on3descendants
- K022149Cardiac Diagnostic System, Model CH2000Cambridge Heart, Inc. · 2002 · 3 generations on2descendants
- K050225Heartwave II Cardiac Diagnostic SystemCambridge Heart, Inc. · 2005 · 4 generations on1descendant
- K013564Modification to Heartwave Alternans Processing System, Model ApsCambridge Heart, Inc. · 2001 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K952417 | Quest Exercise Stress System | Burdick, Inc. | 1996 | — |
| +1 | K012206 | Alternanas Processing System, CH 2000 Cardiac Diagnostic System, Heartwave… | Cambridge Heart, Inc. | 2001 | — |
| +2 | K013565 | Cardiac Diagnostic System, Model CH2000 | Cambridge Heart, Inc. | 2001 | — |
| +3 | K022149 | Cardiac Diagnostic System, Model CH2000 | Cambridge Heart, Inc. | 2002 | — |
| +4 | K050225 | Heartwave II Cardiac Diagnostic System | Cambridge Heart, Inc. | 2005 | — |
| +2 | K013564 | Modification to Heartwave Alternans Processing System, Model Aps | Cambridge Heart, Inc. | 2001 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 3 | 0 |
| 2002 | 2 | 0 |
| 2005 | 1 | 0 |
| 2010 | 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 DSI? 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 DSI device
- #1 K243349 BodyGuardian Remote Monitoring System (BGRMS…score 13.1 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | Quinton Q4500 Stress Test System Named without a submission number | |
| * | — | Burdick E350i Electrocardiograph Named without a submission number |
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K012206 | Alternanas Processing System, CH 2000 Cardiac Diagnostic System, Heartwave Alternans… | 2001 | 6 |
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, K012206 (Cambridge Heart, Inc., 2001) has gone furthest, with 6 descendants of its own.
How does its category compare?
All DSI devicesDSI Detector And Alarm, Arrhythmia: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DSI
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DSI
243in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DSI
18in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DSI
712in 2025
MAUDE reports naming product code DSI, 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 | 7 | 151 | 4 | 64 |
| 2008 | 5 | 70 | 8 | 156 |
| 2009 | 6 | 73 | 3 | 279 |
| 2010 | 6 | 111 | 5 | 823 |
| 2011 | 6 | 114 | 3 | 793 |
| 2012 | 3 | 113 | 1 | 766 |
| 2013 | 1 | — | 0 | 795 |
| 2014 | 4 | 200 | 0 | 1,000 |
| 2015 | 9 | 127 | 0 | 1,645 |
| 2016 | 6 | 224 | 0 | 4,352 |
| 2017 | 0 | — | 0 | 3,594 |
| 2018 | 2 | — | 1 | 3,648 |
| 2019 | 3 | 243 | 4 | 3,485 |
| 2020 | 2 | — | 2 | 3,084 |
| 2021 | 0 | — | 0 | 3,092 |
| 2022 | 0 | — | 1 | 1,638 |
| 2023 | 2 | — | 2 | 1,616 |
| 2024 | 1 | — | 0 | 1,320 |
| 2025 | 1 | — | 18 | 712 |
| 2026 | 1 | — | 1 | — |
What is it indicated for?
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…
Read the full statement (160 words)
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K952417 · printed Nov 4, 2026
Cite this page
510(k) Report. “K952417: Quest Exercise Stress System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K952417
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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