510(k) · Cleared
ClearedQuest Exercise Stress System, Model Configuration 14
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spacelabs Burdick, Inc. · DSI Detector And Alarm, Arrhythmia
Cleared on Aug 20, 2001 after a 110-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 6 later devices descend from it.
- Decided
- Aug 20, 2001
- Review
- 110 days
- Class
- Class II
- Product code
- DSI
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 2 citing it directly.
- This deviceK011339 Quest Exercise Stress System, Model Configuration 14Spacelabs Burdick, Inc. · 2001
- Descendant · cites it directly · 4 of its ownK024283 Cardiodirect, Models 12M, 12I, 12SReynolds Medical, Ltd. · 2003
- Descendant · 2 generations on · 1 of its ownK093211 Carecenter MDCardiac Science Corporation · 2010
- Descendant · 3 generations on · 0 of its ownK123217 CardeascreenCardea Associates, Inc. · 2013
- Descendant · 2 generations on · 0 of its ownK082380 Vicardio 12BEnergy-Lab Technologies GmbH · 2008
- Descendant · 2 generations on · 0 of its ownK062469 Voyager 12Del Mar Reynolds Medical, Ltd. · 2006
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K024283Cardiodirect, Models 12M, 12I, 12SReynolds Medical, Ltd. · 2003 · cites it directly4descendants
- K093211Carecenter MDCardiac Science Corporation · 2010 · 2 generations on1descendant
- K123217CardeascreenCardea Associates, Inc. · 2013 · 3 generations on0descendants
- K082380Vicardio 12BEnergy-Lab Technologies GmbH · 2008 · 2 generations on0descendants
- K062469Voyager 12Del Mar Reynolds Medical, Ltd. · 2006 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K011339 | Quest Exercise Stress System, Model Configuration 14 | Spacelabs Burdick, Inc. | 2001 | — |
| +1 | K024283 | Cardiodirect, Models 12M, 12I, 12S | Reynolds Medical, Ltd. | 2003 | — |
| +2 | K093211 | Carecenter MD | Cardiac Science Corporation | 2010 | — |
| +3 | K123217 | Cardeascreen | Cardea Associates, Inc. | 2013 | — |
| +2 | K082380 | Vicardio 12B | Energy-Lab Technologies GmbH | 2008 | — |
| +2 | K062469 | Voyager 12 | Del Mar Reynolds Medical, Ltd. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (6)
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, K024283 (Reynolds Medical, Ltd., 2003) has gone furthest, with 4 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 | — |
https://510kreport.com/device/K011339 · printed Nov 5, 2026
Cite this page
510(k) Report. “K011339: Quest Exercise Stress System, Model Configuration 14.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K011339
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026