510(k) · Cleared
ClearedCardiosmart
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hellige GmbH · DPS Electrocardiograph
Cleared on May 13, 1996 after a 437-day review. The FDA summary names its predicate without a number. 35 later devices descend from it.
- Decided
- May 13, 1996
- Review
- 437 days
- Class
- Class II
- Product code
- DPS
- Recalls
- None
- Predicates
- 0
35 later devices descend from it, 1 citing it directly.
- This deviceK950989 CardiosmartHellige GmbH · 1996
- Descendant · cites it directly · 34 of its ownK973403 Cardiosmart STMarquette Medical Systems, Inc. · 1998
- Descendant · 2 generations on · 33 of its ownK991014 Case 8000 Exercise Testing SystemGeneral Electric Medical Systems Information Techn · 1999
- Descendant · 3 generations on · 31 of its ownK023380 T-Wave Altermans (Twa) Algorithm OptionGeneral Electric Medical Systems Information Techn · 2002
- Descendant · 3 generations on · 30 of its ownK031561 Cardiosoft/Case Cardiac Testing SystemGe Medical Systems Information Technologies · 2003
- Descendant · 4 generations on · 18 of its ownK092010 PC Ecg, Model SE-1010Edan Instruments, Inc. · 2009
Showing 5 of 35 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 35 · See all- K973403Cardiosmart STMarquette Medical Systems, Inc. · 1998 · cites it directly34descendants
- K991014Case 8000 Exercise Testing SystemGeneral Electric Medical Systems Information Techn · 1999 · 2 generations on33descendants
- K023380T-Wave Altermans (Twa) Algorithm OptionGeneral Electric Medical Systems Information Techn · 2002 · 3 generations on31descendants
- K031561Cardiosoft/Case Cardiac Testing SystemGe Medical Systems Information Technologies · 2003 · 3 generations on30descendants
- K092010PC Ecg, Model SE-1010Edan Instruments, Inc. · 2009 · 4 generations on18descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K950989 | Cardiosmart | Hellige GmbH | 1996 | — |
| +1 | K973403 | Cardiosmart ST | Marquette Medical Systems, Inc. | 1998 | — |
| +2 | K991014 | Case 8000 Exercise Testing System | General Electric Medical Systems Information Techn | 1999 | — |
| +3 | K023380 | T-Wave Altermans (Twa) Algorithm Option | General Electric Medical Systems Information Techn | 2002 | — |
| +3 | K031561 | Cardiosoft/Case Cardiac Testing System | Ge Medical Systems Information Technologies | 2003 | — |
| +4 | K092010 | PC Ecg, Model SE-1010 | Edan Instruments, Inc. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 3 | 0 |
| 2010 | 3 | 0 |
| 2011 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 4 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 3 | 0 |
| 2024 | 1 | 0 |
| 2026 | 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? (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 |
|---|---|---|---|
| * | — | Hellige Cardiognost EK 56 Named without a submission number |
What descends from it? (35)
See all 351 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K973403 | Cardiosmart ST | 1998 | 34 |
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, K973403 (Marquette Medical Systems, Inc., 1998) has gone furthest, with 34 descendants of its own.
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?
CardioSmart is intended to be used for resting ECG and for recording ECG in realtime with and without arrhythmia detection. CardioSmart is intended to be used by trained operators when ECG records are required in the judgement of a physician. The arrhythmia detection portion of CardioSmart is provided to the user for the convenience of automatic documentation. CardioSmart does not provide alarms for arrhythmia detection. CardioSmart is not intended for…
Read the full statement (113 words)
CardioSmart is intended to be used for resting ECG and for recording ECG in realtime with and without arrhythmia detection.
CardioSmart is intended to be used by trained operators when ECG records are required in the judgement of a physician.
The arrhythmia detection portion of CardioSmart is provided to the user for the convenience of automatic documentation.
CardioSmart does not provide alarms for arrhythmia detection.
CardioSmart is not intended for use as a vital signs physiological monitor.
CardioSmart offers no diagnostic opinion to the user. Instead, it provides interpretive statements for which the physician renders his/her own medical opinion.
CardioSmart is not designed for intracardial use.
CardioSmart is not intended for home use.
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/K950989 · printed Nov 4, 2026
Cite this page
510(k) Report. “K950989: Cardiosmart.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K950989
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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