510(k) · Cleared
ClearedQT Guard Plus Analysis System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ge Medical Systems Information Technologies · DPS Electrocardiograph
Cleared on Dec 6, 2012 as substantially equivalent to K981024 (Marquette Medical Systems, Inc., 1998) and 1 other predicate after a 267-day review. Its family tree reaches back 5 generations to 1984.
- Decided
- Dec 6, 2012
- Review
- 267 days
- Class
- Class II
- Product code
- DPS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K842308 (1984). 8 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK842308 12SSL-SCMarquette Electronics, Inc. · 1984
- 4 generations backK980495 Muse Cardiovascular Information SystemMarquette Medical Systems, Inc. · 1998
- 3 generations backK992637 Muse Cardiovascular Information SystemGeneral Electric Medical Systems Information Techn · 1999 · Recalled
- 2 generations backK050614 Muse Cardiology Information SystemGe Medical Systems Information Technologies · 2005 · Recalled
- 1 generation backK072502 Modification to: Muse Cardiology Information SystemGe Medical Systems Information Technologies · 2007 · Recalled
- This deviceK120770 QT Guard Plus Analysis SystemGe Medical Systems Information Technologies · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K842308 | 12SSL-SC | Marquette Electronics, Inc. | 1984 | — |
| −4 | K980495 | Muse Cardiovascular Information System | Marquette Medical Systems, Inc. | 1998 | — |
| −3 | K992637 | Muse Cardiovascular Information System | General Electric Medical Systems Information Techn | 1999 | 1 |
| −2 | K050614 | Muse Cardiology Information System | Ge Medical Systems Information Technologies | 2005 | 1 |
| −1 | K072502 | Modification to: Muse Cardiology Information System | Ge Medical Systems Information Technologies | 2007 | 2 |
| 0 (this device) | K120770 | QT Guard Plus Analysis System | Ge Medical Systems Information Technologies | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1991 | 1 | 0 |
| 1998 | 1 | 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 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? (2)
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 |
|---|---|---|---|
| * | K981024 | QT Dispersion and T Wave Analysis Program (QT Guard Analysis System)Summary page 1…ostic Computer Product Code:. MHX 21CFR 870.1025 00K 21CFR 870.1425 Predicate Device(s): K981024; OT Dispersion and T Wave Analysis Program (CT-Guard Analysis System)… | 1998 |
| * | K072502 | Modification to: Muse Cardiology Information SystemSummary page 1…dicate Device(s): K981024; OT Dispersion and T Wave Analysis Program (CT-Guard Analysis System) K072502 MUSE Cardiology Information System Device Description: OT Guard Plus is a software program that runs on a Micros… | 2007 |
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.
What does this lineage say?
- The line of descent spans 28 years and passes through 4 companies; a new generation was cleared every 5.0 years on median.
- 3 of the 8 ancestors have a recall of any class.
- 1 other device also cites its predicate K981024.
How does its category compare?
All DPS devicesDPS Electrocardiograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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?
QT Guard Plus Analysis System is intended to be used in a hospital, clinic or research environment by competent health professionals. QT Guard Plus Analysis System is intended to perform the analysis of simultaneously acquired 12-lead ECGs for obtaining the measurement of QT interval dispersion and T wave complexity. QT Guard Plus Analysis System is intended to provide only the measurements of the QT dispersion and T wave complexity and is not intended…
Read the full statement (140 words)
QT Guard Plus Analysis System is intended to be used in a hospital, clinic or research environment by competent health professionals.
QT Guard Plus Analysis System is intended to perform the analysis of simultaneously acquired 12-lead ECGs for obtaining the measurement of QT interval dispersion and T wave complexity.
QT Guard Plus Analysis System 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 measurement or diagnosis.
The QT dispersion and T wave complexity measurements produced by QT Guard Plus Analysis System are intended to be used by qualified personnel in evaluating ECG data and the patient in conjunction with patient's clinical history, symptoms other diagnostic tests, as well as the professional's clinical judgment.
QT Guard Plus Analysis System is intended for adult patient populations.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120770 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120770: QT Guard Plus Analysis System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120770
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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