510(k) · Cleared
ClearedCase 8000 Exercise Testing System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
General Electric Medical Systems Information Techn · LOS (no longer in FDA’s product-code list)
Cleared on Oct 20, 1999 as substantially equivalent to K951130 (Marquette Electronics, Inc., 1996) and 1 other predicate after a 208-day review. Its family tree reaches back 2 generations to 1991. 33 later devices descend from it.
- Decided
- Oct 20, 1999
- Review
- 208 days
- Product code
- LOS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K903644 (1991). 4 ancestors in all. 33 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK903644 Series 1500 12-Lead Analysis OptionMarquette Electronics, Inc. · 1991
- 1 generation backK973403 Cardiosmart STMarquette Medical Systems, Inc. · 1998
- This deviceK991014 Case 8000 Exercise Testing SystemGeneral Electric Medical Systems Information Techn · 1999
- Descendant · cites it directly · 31 of its ownK023380 T-Wave Altermans (Twa) Algorithm OptionGeneral Electric Medical Systems Information Techn · 2002
- Descendant · cites it directly · 30 of its ownK031561 Cardiosoft/Case Cardiac Testing SystemGe Medical Systems Information Technologies · 2003
- Descendant · 2 generations on · 18 of its ownK092010 PC Ecg, Model SE-1010Edan Instruments, Inc. · 2009
- Descendant · 2 generations on · 13 of its ownK102854 PC ECGEdan Instruments, Inc. · 2010
- Descendant · 3 generations on · 12 of its ownK131819 PC ECGEdan Instruments, Inc. · 2013
Showing 5 of 33 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 33 · See all- K023380T-Wave Altermans (Twa) Algorithm OptionGeneral Electric Medical Systems Information Techn · 2002 · cites it directly31descendants
- K031561Cardiosoft/Case Cardiac Testing SystemGe Medical Systems Information Technologies · 2003 · cites it directly30descendants
- K092010PC Ecg, Model SE-1010Edan Instruments, Inc. · 2009 · 2 generations on18descendants
- K102854PC ECGEdan Instruments, Inc. · 2010 · 2 generations on13descendants
- K131819PC ECGEdan Instruments, Inc. · 2013 · 3 generations on12descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K903644 | Series 1500 12-Lead Analysis Option | Marquette Electronics, Inc. | 1991 | — |
| −1 | K973403 | Cardiosmart ST | Marquette Medical Systems, Inc. | 1998 | — |
| 0 (this device) | K991014 | Case 8000 Exercise Testing System | General Electric Medical Systems Information Techn | 1999 | — |
| +1 | 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 | — |
| +2 | K092010 | PC Ecg, Model SE-1010 | Edan Instruments, Inc. | 2009 | — |
| +2 | K102854 | PC ECG | Edan Instruments, Inc. | 2010 | — |
| +3 | K131819 | PC ECG | Edan Instruments, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 LOS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K951130 | Cardiosoft/Cardiosys Our OCR of the scanned summary read K251130, FDA’s number for Portable Oxygen Concentrator (JM-P50A) (Jiangsu Jumao X-Care Medical Equipment Co., Ltd.), decided Aug 21, 2025, after this device. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “CardioSoft/CardioSys”. | 1996 |
| * | K973403 | Cardiosmart STSummary page 3…analysis on the resting ECG, providing the user with statements of morphology, rhythm and conduction. No changes have been made to this algorithm - 12SL Analysis System K973403. The CASE 8000 exercise testing system is intended to be used by trained operators under the direct supervision of a licensed he… | 1998 |
| † | K980495 | Muse Cardiovascular Information System | 1998 |
What descends from it? (33)
See all 333 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)
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 8 years and passes through 3 companies; a new generation was cleared every 6.2 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K023380 (General Electric Medical Systems Information Techn, 2002) has gone furthest, with 31 descendants of its own.
- 2 other devices also cite its predicate K951130.
What is it indicated for?
The CASE 8000 exercise testing system is a diagnostic device intended to monitor and record electrocardiographic data from the patient during exercise, as well as perform resting ECG analysis. The intended use of the CASE 8000 exercise testing system is to acquire, process. record, archive, analyze. and output data during a period of physiologic stress or during a resting ECG condition. The CASE 8000 exercise testing system has the ability to calculate…
Read the full statement (286 words)
The CASE 8000 exercise testing system is a diagnostic device intended to monitor and record electrocardiographic data from the patient during exercise, as well as perform resting ECG analysis.
The intended use of the CASE 8000 exercise testing system is to acquire, process. record, archive, analyze. and output data during a period of physiologic stress or during a resting ECG condition. The CASE 8000 exercise testing system has the ability to calculate prognostic scores. A user selectable option can provide printout of prognostic scores’on select reports. A vector loops report is also available.
Ancillary functions include control of an extemal device (typically a treadmill or ergometer) and comrmunications with centralized electronic/digital storage system.
This device uses a computerized analysis program, which can be used as a tool in ECG tracing interpretation.
The device records 12 lead ECG data taken in resting and exercise modes, as well as real-time rhythm and median morphology recordings. The device can perform a 12 lead interpretive analysis oh the resting ECG, providing the user with statements of momphology, rhythm and conduction.
The CASE 8000 exercise testing system is intended to be used by trained operators under the direct supervision of a licensed health care practitioner when exercise or resting ECG records are required,
The CASE 8000 exercise testing system is intended to be used primairily in hospital based exercise testing iaboratories, but can be used in clinics, physician offices, outreach centers or wherever exercise testing is performed. This device is not infended for use with high frequency surgical units.
The CASE 8000 system is not intended to be used as a vital signs physiological monitor.
This equipment will not cause abnormal operation of a patient's cardiac pacemaker or other electronic stimulator.
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/K991014 · printed Nov 4, 2026
Cite this page
510(k) Report. “K991014: Case 8000 Exercise Testing System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K991014
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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