510(k) · Cleared
ClearedT-Wave Alternans (Twa) Algorithm Option
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ge Medical Systems Information Technologies · DQK Computer, Diagnostic, Programmable
Cleared on Oct 30, 2003 after a 77-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below).
- Decided
- Oct 30, 2003
- Review
- 77 days
- Class
- Class II
- Product code
- DQK
- Recalls
- None
- Predicates
- 1
The summary cites one number, which could not be confirmed as its predicate (see the table below).
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K023338 | FDA’s K023338 is Portapres Ambulatory Continuous Non Invasive Blood Pressure Monitor,Model-2 Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2003 |
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 T-Wave Alternans (TWA) Algorithm Option is intended for use in a hospital, doctor's office or clinic environment by competent healthcare professionals for recording ST-T wave morphology fluctuations for patients who are undergoing cardiovascular disease testing. T-Wave Alternans (TWA) describes an electrocardiographic (ECG) pattern that exhibits different ST/T-wave morphologies on alternating beats. The algorithm performs the measurement of this…
Read the full statement (196 words)
The T-Wave Alternans (TWA) Algorithm Option is intended for use in a hospital, doctor's office or clinic environment by competent healthcare professionals for recording ST-T wave morphology fluctuations for patients who are undergoing cardiovascular disease testing.
T-Wave Alternans (TWA) describes an electrocardiographic (ECG) pattern that exhibits different ST/T-wave morphologies on alternating beats. The algorithm performs the measurement of this variation at an accuracy and resolution of 1-microvolt. The TWA Algorithm Option permits visual confirmation of TWA by displaying the original ECG along with representative complexes made from a moving average of every other beat.
The TWA Algorithm measurements have been found to be predictive of arrhythmic death and can be used for the purposes of risk stratification. The TWA Algorithm Option allows the user to specify the maximal heart rate for valid TWA measurements and the specific heart rate to be attained before TWA is measured.
The TWA Algorithm Option is intended to provide only the measurements of the fluctuations of the ST-T-waves. TWA measurements are intended for qualified personnel in evaluating the patient in conjunction with the patient's clinical history, symptoms, other diagnostic tests, as well as the professional's clinical judgment. No interpretation is generated.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032513 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032513: T-Wave Alternans (Twa) Algorithm Option.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032513
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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