510(k) · Cleared
ClearedQuinton Q-Stress, Model 000483
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Quinton, Inc. · DPS Electrocardiograph
Cleared on Aug 9, 2000 after an 89-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it.
- Decided
- Aug 9, 2000
- Review
- 89 days
- Class
- Class II
- Product code
- DPS
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 3 citing it directly.
- This deviceK001492 Quinton Q-Stress, Model 000483Quinton, Inc. · 2000
- Descendant · cites it directly · 2 of its ownK022618 X-Scribe IIMortara Instrument, Inc. · 2002
- Descendant · 2 generations on · 0 of its ownK152944 Xscribe Stress Exercise Testing Systems, Q-Stress Stress Exercise…Mortara Instrument, Inc. · 2016 · Recalled
- Descendant · 2 generations on · 0 of its ownK092663 Eli 350 ElectrocardiographMortara Instrument, Inc. · 2009 · Recalled
- Descendant · cites it directly · 0 of its ownK082173 Q-Stress and Heartstride, Models Qstress/Q40 and H4/H4SCardiac Science Corporation · 2008 · Recalled
- Descendant · cites it directly · 0 of its ownK052898 Iqmark EZ StressBrentwood Medical Technology Corp. · 2006
Most influential descendants
Showing 5 of 5 · See all- K022618X-Scribe IIMortara Instrument, Inc. · 2002 · cites it directly2descendants
- K152944Xscribe Stress Exercise Testing Systems, Q-Stress Stress Exercise Testing SystemsMortara Instrument, Inc. · 2016 · 2 generations on0descendants
- K092663Eli 350 ElectrocardiographMortara Instrument, Inc. · 2009 · 2 generations on0descendants
- K082173Q-Stress and Heartstride, Models Qstress/Q40 and H4/H4SCardiac Science Corporation · 2008 · cites it directly0descendants
- K052898Iqmark EZ StressBrentwood Medical Technology Corp. · 2006 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K001492 | Quinton Q-Stress, Model 000483 | Quinton, Inc. | 2000 | — |
| +1 | K022618 | X-Scribe II | Mortara Instrument, Inc. | 2002 | — |
| +2 | K152944 | Xscribe Stress Exercise Testing Systems, Q-Stress Stress Exercise Testing… | Mortara Instrument, Inc. | 2016 | 5 |
| +2 | K092663 | Eli 350 Electrocardiograph | Mortara Instrument, Inc. | 2009 | 1 |
| +1 | K082173 | Q-Stress and Heartstride, Models Qstress/Q40 and H4/H4S | Cardiac Science Corporation | 2008 | 1 |
| +1 | K052898 | Iqmark EZ Stress | Brentwood Medical Technology Corp. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2016 | 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 DPS? 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 DPS device
- #1 K212112 Cardiologs Holter Platformscore 18.6 · 5 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? (5)
3 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, K022618 (Mortara Instrument, Inc., 2002) has gone furthest, with 2 descendants of its own.
How does its category compare?
All DPS devicesDPS Electrocardiograph: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DPS
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DPS
163in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DPS
3in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · DPS
55in 2025
MAUDE reports naming product code DPS, 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 | 11 | 87 | 2 | 9 |
| 2008 | 13 | 31 | 0 | 17 |
| 2009 | 14 | 84 | 1 | 14 |
| 2010 | 11 | 104 | 2 | 21 |
| 2011 | 22 | 154 | 1 | 121 |
| 2012 | 12 | 117 | 0 | 56 |
| 2013 | 10 | 134 | 0 | 15 |
| 2014 | 11 | 253 | 0 | 15 |
| 2015 | 8 | 178 | 0 | 30 |
| 2016 | 11 | 229 | 0 | 12 |
| 2017 | 9 | 177 | 0 | 15 |
| 2018 | 14 | 221 | 0 | 19 |
| 2019 | 3 | 178 | 9 | 27 |
| 2020 | 6 | 224 | 2 | 59 |
| 2021 | 5 | 135 | 1 | 24 |
| 2022 | 6 | 244 | 1 | 59 |
| 2023 | 10 | 236 | 3 | 54 |
| 2024 | 8 | 260 | 4 (1) | 64 |
| 2025 | 6 | 163 | 3 | 55 |
| 2026 | 6 | 258 | 4 | — |
https://510kreport.com/device/K001492 · printed Nov 6, 2026
Cite this page
510(k) Report. “K001492: Quinton Q-Stress, Model 000483.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K001492
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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