510(k) · Cleared
Recalled · 2009Ascentia Heartstation Ecg Management System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Heartlab, Inc. · DPS Electrocardiograph
Cleared on Jun 29, 2005 as substantially equivalent to K031970 (Siemens Medical Solutions USA, Inc., 2003) and 3 other predicates after an 85-day review. Its family tree reaches back 4 generations to 1984. 13 later devices descend from it. It has been recalled once.
- Decided
- Jun 29, 2005
- Review
- 85 days
- Class
- Class II
- Product code
- DPS
- Recalls
- 1
- Predicates
- 4
Its longest line of descent runs back 4 generations to K842308 (1984). 14 ancestors in all. 13 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK842308 12SSL-SCMarquette Electronics, Inc. · 1984
- 3 generations backK980495 Muse Cardiovascular Information SystemMarquette Medical Systems, Inc. · 1998
- 2 generations backK992637 Muse Cardiovascular Information SystemGeneral Electric Medical Systems Information Techn · 1999 · Recalled
- 1 generation backK031970 Infinity MegacareSiemens Medical Solutions USA, Inc. · 2003
- This deviceK050858 Ascentia Heartstation Ecg Management SystemHeartlab, Inc. · 2005
- Descendant · cites it directly · 8 of its ownK061905 Horizon Cardiology Ecg-Mckesson's Ecg Management System, Model 1.0Medcon, Ltd. · 2006
- Descendant · 2 generations on · 7 of its ownK113515 Horizon Cardiology Ecg ManagementMckesson Israel, Ltd. · 2012 · Recalled
- Descendant · 3 generations on · 6 of its ownK133534 Mckesson Cardiology Ecg MobileMckesson Israel, Ltd. · 2014
- Descendant · 4 generations on · 4 of its ownK151774 CARESTREAM Vue MotionCarestream Health, Inc. · 2015 · Recalled
- Descendant · 5 generations on · 3 of its ownK170434 Enterprise Imaging XERO Viewer 8.1Agfa Healthcare N.V. · 2017 · Recalled
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K061905Horizon Cardiology Ecg-Mckesson's Ecg Management System, Model 1.0Medcon, Ltd. · 2006 · cites it directly8descendants
- K113515Horizon Cardiology Ecg ManagementMckesson Israel, Ltd. · 2012 · 2 generations on7descendants
- K133534Mckesson Cardiology Ecg MobileMckesson Israel, Ltd. · 2014 · 3 generations on6descendants
- K151774CARESTREAM Vue MotionCarestream Health, Inc. · 2015 · 4 generations on4descendants
- K170434Enterprise Imaging XERO Viewer 8.1Agfa Healthcare N.V. · 2017 · 5 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K842308 | 12SSL-SC | Marquette Electronics, Inc. | 1984 | — |
| −3 | K980495 | Muse Cardiovascular Information System | Marquette Medical Systems, Inc. | 1998 | — |
| −2 | K992637 | Muse Cardiovascular Information System | General Electric Medical Systems Information Techn | 1999 | 1 |
| −1 | K031970 | Infinity Megacare | Siemens Medical Solutions USA, Inc. | 2003 | — |
| 0 (this device) | K050858 | Ascentia Heartstation Ecg Management System | Heartlab, Inc. | 2005 | — |
| +1 | K061905 | Horizon Cardiology Ecg-Mckesson's Ecg Management System, Model 1.0 | Medcon, Ltd. | 2006 | — |
| +2 | K113515 | Horizon Cardiology Ecg Management | Mckesson Israel, Ltd. | 2012 | 2 |
| +3 | K133534 | Mckesson Cardiology Ecg Mobile | Mckesson Israel, Ltd. | 2014 | — |
| +4 | K151774 | CARESTREAM Vue Motion | Carestream Health, Inc. | 2015 | 1 |
| +5 | K170434 | Enterprise Imaging XERO Viewer 8.1 | Agfa Healthcare N.V. | 2017 | 2 |
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 |
|---|---|---|
| 2006 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2020 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 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 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? (4)
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 |
|---|---|---|---|
| * | K031970 | Infinity MegacareSummary page 3…ollowing predicate devices currently in commercial distribution: Model Manufacturer Infinity MegaCare (k031970) Driger-Siemens Eclipse ECG (k946281)… | 2003 |
| * | K946281 | Eclipse 4 ElectrocardiographSummary page 3…Manufacturer Infinity MegaCare (k031970) Driger-Siemens Eclipse ECG (k946281) Burdick Tracemaster ECG Management System (k032103)… | 1996 |
| * | K032103 | Philips Tracemaster Ecg Management System, Models M5100A and M5101ASummary page 3…Driger-Siemens Eclipse ECG (k946281) Burdick Tracemaster ECG Management System (k032103) Philips Pyramis ECG Management System (k032038) Quinton Predicate d… | 2003 |
| * | K032038 | Pyramis Ecg Management System Model Numbers, 92600 and 92601Summary page 3…Burdick Tracemaster ECG Management System (k032103) Philips Pyramis ECG Management System (k032038) Quinton Predicate device specifications comparison: Principal Predic… | 2003 |
What descends from it? (13)
See all 132 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 7, 2009 | Not classified | Z-0366-2010 | Other | HeartStation does not refresh content changes to the PDF reports that are printed emailed or faxed from the Index page. This may lead to a discrepancy in patient demographics between what is displayed in the HeartStation Client interface… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 21 years and passes through 5 companies; a new generation was cleared every 3.8 years on median.
- 1 of the 14 ancestors has a recall of any class.
- Of its descendants, K061905 (Medcon, Ltd., 2006) has gone furthest, with 8 descendants of its own.
- 1 other device also cites its predicate K031970.
How does its category compare?
All DPS devicesDPS Electrocardiograph: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
The Heartlab HeartStation T 'M ECG Management System is a comprehensive data management solution which automates the processing, storage and display ofT electrocardiograms (ECGs) throughout a healthcare enterprise. HeartStation M accepts standard 12-lead ECGs, which originate from any one of a variety of manufacturers' cardiographs and patient monitors, and normalizes them to a common format. ECGs are then measured, interpreted, compared to previous ECGs…
Read the full statement (114 words)
The Heartlab HeartStation T 'M ECG Management System is a comprehensive data
management solution which automates the processing, storage and display ofT
electrocardiograms (ECGs) throughout a healthcare enterprise. HeartStation M accepts
standard 12-lead ECGs, which originate from any one of a variety of manufacturers'
cardiographs and patient monitors, and normalizes them to a common format. ECGs
are then measured, interpreted, compared to previous ECGs ( 4serial comparison"),
optionally printed and stored with a preliminary diagnosis. A graphical user interface
allows a physician to review these computer-generated reports, modify them or add
comments as appropriate, electronically apply his or her signature and trigger the
automatic distribution of final, confirmed diagnostic reports to other care providers.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050858 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050858: Ascentia Heartstation Ecg Management System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050858
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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