510(k) · Cleared
ClearedCase Cardiac Testing System, CS Cardiac Testing System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ge Medical Systems Information Technologies GmbH · DQK Computer, Diagnostic, Programmable
Cleared on Feb 16, 2011 as substantially equivalent to K031561 (Ge Medical Systems Information Technologies, 2003) after a 62-day review. Its family tree reaches back 5 generations to 1991. 1 later device descends from it.
- Decided
- Feb 16, 2011
- Review
- 62 days
- Class
- Class II
- Product code
- DQK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K903644 (1991). 8 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK903644 Series 1500 12-Lead Analysis OptionMarquette Electronics, Inc. · 1991
- 4 generations backK973403 Cardiosmart STMarquette Medical Systems, Inc. · 1998
- 3 generations backK991014 Case 8000 Exercise Testing SystemGeneral Electric Medical Systems Information Techn · 1999
- 2 generations backK023380 T-Wave Altermans (Twa) Algorithm OptionGeneral Electric Medical Systems Information Techn · 2002
- 1 generation backK031561 Cardiosoft/Case Cardiac Testing SystemGe Medical Systems Information Technologies · 2003
- This deviceK103678 Case Cardiac Testing System, CS Cardiac Testing SystemGe Medical Systems Information Technologies GmbH · 2011
- Descendant · cites it directly · 0 of its ownK231870 CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing…Ge Medical Systems Information Technologies, Inc. · 2023 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K231870CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing SystemGe Medical Systems Information Technologies, Inc. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K903644 | Series 1500 12-Lead Analysis Option | Marquette Electronics, Inc. | 1991 | — |
| −4 | K973403 | Cardiosmart ST | Marquette Medical Systems, Inc. | 1998 | — |
| −3 | K991014 | Case 8000 Exercise Testing System | General Electric Medical Systems Information Techn | 1999 | — |
| −2 | K023380 | T-Wave Altermans (Twa) Algorithm Option | General Electric Medical Systems Information Techn | 2002 | — |
| −1 | K031561 | Cardiosoft/Case Cardiac Testing System | Ge Medical Systems Information Technologies | 2003 | — |
| 0 (this device) | K103678 | Case Cardiac Testing System, CS Cardiac Testing System | Ge Medical Systems Information Technologies GmbH | 2011 | — |
| +1 | K231870 | CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System | Ge Medical Systems Information Technologies, Inc. | 2023 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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? (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 |
|---|---|---|---|
| * | K031561 | Cardiosoft/Case Cardiac Testing SystemSummary page 1…e diagnostic computer Product Code: DQK Preicte evce~):CardiaSoft / CASE Cardiac Testing System K031561 Testing System Device Description: Th… | 2003 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K231870 | CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System | 2023 | 0 |
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 20 years and passes through 5 companies; a new generation was cleared every 3.1 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K231870 (Ge Medical Systems Information Technologies, Inc., 2023) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate K031561.
How does its category compare?
All DQK devicesDQK Computer, Diagnostic, Programmable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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?
The CASE Cardiac Testing System and CS Cardiac Testing System are designed to be used for resting ECG, stress test ECG, Spirometery, Ambulatory Blood Pressure and for recording ECG in real-time with and without arrhythmia detection. The CASE isa turnkey product utilizing the CS software. The CS will be offered as a software only package including a front end for data acquisition. CASE Cardiac Testing System and CS Cardiac Testing System are intended to…
Read the full statement (411 words)
The CASE Cardiac Testing System and CS Cardiac Testing System are designed to be used for resting ECG, stress test ECG, Spirometery, Ambulatory Blood Pressure and for recording ECG in real-time with and without arrhythmia detection. The CASE isa turnkey product utilizing the CS software. The CS will be offered as a software only package including a front end for data acquisition.
CASE Cardiac Testing System and CS Cardiac Testing System are intended to be used by trained operators under direct supervision of a licensed health care practitioner on adult and pediatric patients.
The CASE Cardiac Testing System and CS Cardiac Testing System are designed to acquire, process, record, archive, analyze and output (12 and 15 lead) ECG data during a period of physiologic stress or during a resting ECG test, acquire data from ancillary devices (such as Spirometry and Ambulatory Blood Pressure), provide median morphology recordings and record ECG in real-time with and without arrhythmia detection. The arrhythmia detection portion of CASE Cardiac Testing System and CS Cardiac Testing System are provided to the user for the convenience of automatic detection of arrhythmias but does not provide alarms. CASE Cardiac Testing System and CS Cardiac Testing System provide the control of external devices (typically a treadmill or Ergometer) and communicate with centralized electron ic/dig italI storage system via network. CASE Cardiac Testing System and CS Cardiac Testing System provide a user selectable option for printouts of prognostic scores on select reports. Vector loops are also available.
CASE Cardiac Testing System and CS Cardiac Testing System can be configured in a network environment for multiple CASE stations and CS stations allowing the user to create a central database of patient demographics and collected patient physiological data.
CASE Cardiac Testing System and CS Cardiac Testing System are intended to be used primarily in the hospital but can be used in clinics, physician offices, outreach centers or wherever exercise, stress testing, ECG, Spirometry or ambulatory blood pressure testing is performed.
CASE Cardiac Testing System and CS Cardiac Testing System offer no diagnostic opinion to the user. instead it provides interpretive statements of morphology, rhythm, and conduction for which the physician renders his/her own medical opinion.
CASE Cardiac Testing System and CS Cardiac Testing System are not intended to be used as a transport device or for home use.
CASE Cardiac Testing System anid CS Cardiac Testing System are not intended for the use as a vital signs physiological monitor or for intracardiac use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103678 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103678: Case Cardiac Testing System, CS Cardiac Testing System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103678
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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