510(k) · Cleared
Recalled · 2009Q-Stress and Heartstride, Models Qstress/Q40 and H4/H4S
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cardiac Science Corporation · DPS Electrocardiograph
Cleared on Aug 26, 2008 as substantially equivalent to K001492 (Quinton, Inc., 2000) after a 25-day review. Its family tree reaches back 1 generation to 2000. It has been recalled once.
- Decided
- Aug 26, 2008
- Review
- 25 days
- Class
- Class II
- Product code
- DPS
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K001492 (2000). No later device cites it as a predicate yet.
- Root · 1 generation backK001492 Quinton Q-Stress, Model 000483Quinton, Inc. · 2000
- This deviceK082173 Q-Stress and Heartstride, Models Qstress/Q40 and H4/H4SCardiac Science Corporation · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K001492 | Quinton Q-Stress, Model 000483 | Quinton, Inc. | 2000 | — |
| 0 (this device) | K082173 | Q-Stress and Heartstride, Models Qstress/Q40 and H4/H4S | Cardiac Science Corporation | 2008 | — |
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 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? (1)
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 |
|---|---|---|---|
| * | K001492 | Quinton Q-Stress, Model 000483Summary page 1…Electrocardiograph B. Predicate Devices Device Name Premarket Notification Q-Stress K001492 C. Device description Q-Stress and HeartStride are diagnostic devices capable of ECG monitoring; ST analysis… | 2000 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 30, 2009 | Not classified | Z-1757-2010 | Other | 28 stress and rehab treadmills manufactured between September 2006 and January 2009 may not have received adequate electrical safety testing prior to being shipped from the factory. If these components break down in the field, a patient… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- 2 other devices also cite its predicate K001492.
How does its category compare?
All DPS devicesDPS Electrocardiograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
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 | — |
What is it indicated for?
The device is intended to acquire, process, record, archive, analyze, and output electrocardiographic data during physiologic stress testing. The device may interface with external devices, including a treadmill or ergometer for dynamic exercise evaluation, non-invasive blood pressure equipment, and computer communications equipment. The device is intended for use in a clinical setting by trained personnel under the supervision of a licensed physician. The device is intended for adult populations, typically symptomatic. The device is not intended to be used as a vital signs physiological monitor.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082173 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082173: Q-Stress and Heartstride, Models Qstress/Q40 and H4/H4S.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082173
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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