510(k) · Cleared
ClearedStresswriter Exercise Testing System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hewlett-Packard Co. · DQK Computer, Diagnostic, Programmable
Cleared on Jun 17, 1996 after a 97-day review. The FDA summary names its predicate without a number.
- Decided
- Jun 17, 1996
- Review
- 97 days
- Class
- Class II
- Product code
- DQK
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
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 DQK? 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 DQK device
- #1 K213682 HemoSphere Advanced Monitor, HemoSphere…score 26.6 · 28 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 |
|---|---|---|---|
| * | — | M2488A StressWriter Exercise Testing System Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
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.
How does its category compare?
All DQK devicesDQK Computer, Diagnostic, Programmable: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DQK
23so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · DQK
95in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQK
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DQK
433in 2025
MAUDE reports naming product code DQK, 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 | 13 | 83 | 4 | 18 |
| 2008 | 4 | 70 | 1 | 34 |
| 2009 | 12 | 93 | 2 | 40 |
| 2010 | 9 | 64 | 3 | 49 |
| 2011 | 12 | 69 | 2 | 55 |
| 2012 | 7 | 74 | 3 | 129 |
| 2013 | 13 | 68 | 1 | 180 |
| 2014 | 9 | 90 | 4 | 115 |
| 2015 | 7 | 125 | 2 | 131 |
| 2016 | 15 | 190 | 0 | 340 |
| 2017 | 7 | 146 | 2 | 252 |
| 2018 | 14 | 150 | 6 | 261 |
| 2019 | 15 | 113 | 1 | 218 |
| 2020 | 16 | 123 | 1 | 215 |
| 2021 | 16 | 132 | 1 | 351 |
| 2022 | 19 | 136 | 2 | 319 |
| 2023 | 21 | 133 | 2 | 340 |
| 2024 | 13 | 100 | 24 | 557 |
| 2025 | 22 | 95 | 1 | 433 |
| 2026 | 23 | 151 | 2 | — |
What is it indicated for?
The intended use of the M2488A HP StressWriter Exercise Testing System is to produce accurate measurements of the heart's response to exertion. Exercise electrocardiography is a commonly used non-invasive technique used to help detect coronary artery disease. This type of diagnostic tool can assist a physician in two important ways: - Report ECG changes which may indicate whether coronary circulation is able to increase the oxygen supply to muscle tissue…
Read the full statement (213 words)
The intended use of the M2488A HP StressWriter Exercise Testing System is to produce accurate measurements of the heart's response to exertion.
Exercise electrocardiography is a commonly used non-invasive technique used to help detect coronary artery disease. This type of diagnostic tool can assist a physician in two important ways:
- Report ECG changes which may indicate whether coronary circulation is able to increase the oxygen supply to muscle tissue in response to increased demand.
- Assess the patient's overall exercise capacity.
Typical applications of exercise electrocardiography could include the following:
- Evaluating patients with symptoms suggestive of coronary disease
- Determining the prognosis and severity of coronary disease
- Evaluating the effects of medical and surgical therapy
- Screening for latent coronary disease
- Evaluating patients with stable congestive heart failure
- Evaluating patients with arrhythmias
- Evaluating the patient's functional capacity, and developing exercise prescriptions
- Evaluating patients with congenital heart disease
- Evaluating patients with exertional shortness of breath, dizziness, or syncope
- Evaluating cardiac rehabilitation
- Evaluating patients with rate-responsive pacemakers
- Evaluating sports medicine patients
Physicians typically evaluate the electrocardiogram for ST segment depression or elevation and or QRS alterations. This information is used by a physician in conjunction with other clinical information to diagnose and provide treatment.
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/K961009 · printed Nov 6, 2026
Cite this page
510(k) Report. “K961009: Stresswriter Exercise Testing System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K961009
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026