510(k) · Cleared
ClearedQT Dispersion and T Wave Analysis Program (QT Guard Analysis System)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Marquette Medical Systems, Inc. · LOS (no longer in FDA’s product-code list)
Cleared on Oct 6, 1998 after a 201-day review. The FDA summary names its predicate without a number. 87 later devices descend from it.
- Decided
- Oct 6, 1998
- Review
- 201 days
- Product code
- LOS
- Recalls
- None
- Predicates
- 0
87 later devices descend from it, 2 citing it directly.
- This deviceK981024 QT Dispersion and T Wave Analysis Program (QT Guard Analysis System)Marquette Medical Systems, Inc. · 1998
- Descendant · cites it directly · 85 of its ownK010949 2010 Plus Holter for WindowsAgilent Technologies · 2001
- Descendant · 2 generations on · 46 of its ownK042108 Vista PlusNovacor · 2005
- Descendant · 3 generations on · 40 of its ownK071641 Reveal XT; Insertable Cardiac Monitor (Model 9529), Patient…Medtronic, Inc. · 2007
- Descendant · 3 generations on · 30 of its ownK071655 Reveal DX Insertable Cardiac Monitor, Reveal Patient Assistant…Medtronic, Inc. · 2007
- Descendant · 4 generations on · 28 of its ownK082475 Reveal XT Insertable Cardiac Monitor, Model 9529, Revel DX…Medtronic, Inc. · 2008
Showing 5 of 87 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 87 · See all- K0109492010 Plus Holter for WindowsAgilent Technologies · 2001 · cites it directly85descendants
- K042108Vista PlusNovacor · 2005 · 2 generations on46descendants
- K071641Reveal XT; Insertable Cardiac Monitor (Model 9529), Patient Assistant (Model 9539)Medtronic, Inc. · 2007 · 3 generations on40descendants
- K071655Reveal DX Insertable Cardiac Monitor, Reveal Patient Assistant, Model (S) 9528,9538Medtronic, Inc. · 2007 · 3 generations on30descendants
- K082475Reveal XT Insertable Cardiac Monitor, Model 9529, Revel DX Insertable Cardiac Monitor…Medtronic, Inc. · 2008 · 4 generations on28descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K981024 | QT Dispersion and T Wave Analysis Program (QT Guard Analysis System) | Marquette Medical Systems, Inc. | 1998 | — |
| +1 | K010949 | 2010 Plus Holter for Windows | Agilent Technologies | 2001 | — |
| +2 | K042108 | Vista Plus | Novacor | 2005 | — |
| +3 | K071641 | Reveal XT; Insertable Cardiac Monitor (Model 9529), Patient Assistant (Model… | Medtronic, Inc. | 2007 | — |
| +3 | K071655 | Reveal DX Insertable Cardiac Monitor, Reveal Patient Assistant, Model (S)… | Medtronic, Inc. | 2007 | — |
| +4 | K082475 | Reveal XT Insertable Cardiac Monitor, Model 9529, Revel DX Insertable Cardiac… | Medtronic, Inc. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 3 | 0 |
| 2006 | 1 | 0 |
| 2007 | 3 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 3 | 0 |
| 2013 | 3 | 0 |
| 2014 | 4 | 0 |
| 2015 | 7 | 0 |
| 2016 | 7 | 0 |
| 2017 | 7 | 0 |
| 2018 | 2 | 0 |
| 2019 | 4 | 0 |
| 2020 | 6 | 0 |
| 2021 | 4 | 0 |
| 2022 | 4 | 0 |
| 2023 | 7 | 0 |
| 2024 | 2 | 0 |
| 2025 | 6 | 0 |
| 2026 | 4 | 0 |
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 LOS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | — | Marquette 12SL Analysis Program Named without a submission number |
What descends from it? (87)
See all 872 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, K010949 (Agilent Technologies, 2001) has gone furthest, with 85 descendants of its own.
What is it indicated for?
QT Guard Analysis System is intended to be used in a hospital or clinic environment by competent health professionals. QT Guard Analysis System is intended to perform the analysis of simultaneously acquired 12-lead ECG for obtaining the measurements of QT interval dispersion and T wave complexity. QT-Guard Analysis Program is intended to provide only the measurements of the QT dispersion and T wave complexity and is not intended to produce any…
Read the full statement (130 words)
QT Guard Analysis System is intended to be used in a hospital or clinic environment by competent health professionals.
QT Guard Analysis System is intended to perform the analysis of simultaneously acquired 12-lead ECG for obtaining the measurements of QT interval dispersion and T wave complexity.
QT-Guard Analysis Program is intended to provide only the measurements of the QT dispersion and T wave complexity and is not intended to produce any interpretation of those measurements or diagnosis.
The QT dispersion and T wave complexity measurements produced by QT Guard Analysis System are intended to be used by qualified personnel in evaluating the patient in conjunction with patient's clinical history, symptoms, other diagnostic tests, as well as the professional’s clinical judgment.
QT Guard Analysis System is intended for adult patient populations.
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/K981024 · printed Nov 4, 2026
Cite this page
510(k) Report. “K981024: QT Dispersion and T Wave Analysis Program (QT Guard Analysis System).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K981024
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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