510(k) · Cleared
Recalled · Class II · 2020Horizon Cardiology Ecg Management
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mckesson Israel, Ltd. · DQK Computer, Diagnostic, Programmable
Cleared on Mar 16, 2012 as substantially equivalent to K061905 (Medcon, Ltd., 2006) after a 109-day review. Its family tree reaches back 6 generations to 1984. 7 later devices descend from it. It has been recalled 2 times.
- Decided
- Mar 16, 2012
- Review
- 109 days
- Class
- Class II
- Product code
- DQK
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 6 generations to K842308 (1984). 16 ancestors in all. 7 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK842308 12SSL-SCMarquette Electronics, Inc. · 1984
- 5 generations backK980495 Muse Cardiovascular Information SystemMarquette Medical Systems, Inc. · 1998
- 4 generations backK992637 Muse Cardiovascular Information SystemGeneral Electric Medical Systems Information Techn · 1999 · Recalled
- 3 generations backK031970 Infinity MegacareSiemens Medical Solutions USA, Inc. · 2003
- 2 generations backK050858 Ascentia Heartstation Ecg Management SystemHeartlab, Inc. · 2005 · Recalled
- 1 generation backK061905 Horizon Cardiology Ecg-Mckesson's Ecg Management System, Model 1.0Medcon, Ltd. · 2006
- This deviceK113515 Horizon Cardiology Ecg ManagementMckesson Israel, Ltd. · 2012
- Descendant · cites it directly · 6 of its ownK133534 Mckesson Cardiology Ecg MobileMckesson Israel, Ltd. · 2014
- Descendant · 2 generations on · 4 of its ownK151774 CARESTREAM Vue MotionCarestream Health, Inc. · 2015 · Recalled
- Descendant · 3 generations on · 3 of its ownK170434 Enterprise Imaging XERO Viewer 8.1Agfa Healthcare N.V. · 2017 · Recalled
- Descendant · 4 generations on · 1 of its ownK200822 BraidBraid.Health · 2020
- Descendant · 4 generations on · 0 of its ownK252199 AGFA HealthCare Enterprise ImagingAgfa Healthcare N.V. · 2025
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K133534Mckesson Cardiology Ecg MobileMckesson Israel, Ltd. · 2014 · cites it directly6descendants
- K151774CARESTREAM Vue MotionCarestream Health, Inc. · 2015 · 2 generations on4descendants
- K170434Enterprise Imaging XERO Viewer 8.1Agfa Healthcare N.V. · 2017 · 3 generations on3descendants
- K200822BraidBraid.Health · 2020 · 4 generations on1descendant
- K252199AGFA HealthCare Enterprise ImagingAgfa Healthcare N.V. · 2025 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K842308 | 12SSL-SC | Marquette Electronics, Inc. | 1984 | — |
| −5 | K980495 | Muse Cardiovascular Information System | Marquette Medical Systems, Inc. | 1998 | — |
| −4 | K992637 | Muse Cardiovascular Information System | General Electric Medical Systems Information Techn | 1999 | 1 |
| −3 | K031970 | Infinity Megacare | Siemens Medical Solutions USA, Inc. | 2003 | — |
| −2 | K050858 | Ascentia Heartstation Ecg Management System | Heartlab, Inc. | 2005 | 1 |
| −1 | K061905 | Horizon Cardiology Ecg-Mckesson's Ecg Management System, Model 1.0 | Medcon, Ltd. | 2006 | — |
| 0 (this device) | K113515 | Horizon Cardiology Ecg Management | Mckesson Israel, Ltd. | 2012 | — |
| +1 | K133534 | Mckesson Cardiology Ecg Mobile | Mckesson Israel, Ltd. | 2014 | — |
| +2 | K151774 | CARESTREAM Vue Motion | Carestream Health, Inc. | 2015 | 1 |
| +3 | K170434 | Enterprise Imaging XERO Viewer 8.1 | Agfa Healthcare N.V. | 2017 | 2 |
| +4 | K200822 | Braid | Braid.Health | 2020 | — |
| +4 | K252199 | AGFA HealthCare Enterprise Imaging | Agfa Healthcare N.V. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 2003 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 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 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? (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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K061905 | Horizon Cardiology Ecg-Mckesson's Ecg Management System, Model 1.0Summary page 1…C.F.R. § 870.1425 Product code: DQK Device Class: Class 11 Predicate Device: Medcon Ltd., Horizon Cardiology ECU (K06 1905), GE Healthcare, GE MUSE® Cardiology Inform-ation System (K 101… | 2006 |
| Kept off the family tree | K101322 | FDA’s K101322 is Joinsoon Electronics MFG CO., LTD Infrared Ear Thermometer, Model TT-001 Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2010 |
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K133534 | Mckesson Cardiology Ecg Mobile | 2014 | 6 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 10, 2020 | Class II | Z-1682-2020 | Device Design | Inaccurate estimation of the heart rate may occur in instances where the user is estimating heart rate counting grid squares using the Sequential ECG format |
| Dec 19, 2014 | Class II | Z-0910-2015 | Software design | An ECG procedure time stamp is incorrect, due to a software error in the McKesson Cardiology ECG Management with software versions 13.1 and 13.1.1. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 28 years and passes through 7 companies; a new generation was cleared every 3.8 years on median.
- 2 of the 16 ancestors have a recall of any class.
- Of its descendants, K133534 (Mckesson Israel, Ltd., 2014) has gone furthest, with 6 descendants of its own.
How does its category compare?
All DQK devicesDQK Computer, Diagnostic, Programmable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
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?
Horizon Cardiology Tm ECG Management is a software application designed to import, display, store, analyze, distribute and manage information related to ECG procedures of adult and pediatric patients from external ECG devices. Horizon Cardiology Tm EGG Management allows analysis or reanalysis of resting EGGs and provides preliminary data for editing and confirmation by an over-reading physician. Horizon Cardiology EGG Management can also provide a serial…
Read the full statement (125 words)
Horizon Cardiology Tm ECG Management is a software application designed to import, display, store, analyze, distribute and manage information related to ECG procedures of adult and pediatric patients from external ECG devices.
Horizon Cardiology Tm EGG Management allows analysis or reanalysis of resting EGGs and provides preliminary data for editing and confirmation by an over-reading physician. Horizon Cardiology EGG Management can also provide a serial comparison of resting EGG data to facilitate review of a patient's current ECG with previous EGGs of the same patient.
Horizon GardiologyTm ECG Management is intended to be used under the direct supervision of a licensed healthcare practitioner and by trained operators in a hospital or facility providing patient care. Horizon Cardiology EGG Management is not intended for real-time monitoring.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113515 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113515: Horizon Cardiology Ecg Management.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113515
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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