510(k) · Cleared
ClearedCardiosoft/Cardiosys
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Marquette Electronics, Inc. · LOS (no longer in FDA’s product-code list)
Cleared on Apr 4, 1996 after a 388-day review. The FDA summary names its predicate without a number. 35 later devices descend from it.
- Decided
- Apr 4, 1996
- Review
- 388 days
- Product code
- LOS
- Recalls
- None
- Predicates
- 0
35 later devices descend from it, 3 citing it directly.
- This deviceK951130 Cardiosoft/CardiosysMarquette Electronics, Inc. · 1996
- Descendant · cites it directly · 34 of its ownK973403 Cardiosmart STMarquette Medical Systems, Inc. · 1998
- Descendant · cites it directly · 33 of its ownK991014 Case 8000 Exercise Testing SystemGeneral Electric Medical Systems Information Techn · 1999
- Descendant · 2 generations on · 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
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 · cites it directly33descendants
- K023380T-Wave Altermans (Twa) Algorithm OptionGeneral Electric Medical Systems Information Techn · 2002 · 2 generations on31descendants
- K031561Cardiosoft/Case Cardiac Testing SystemGe Medical Systems Information Technologies · 2003 · cites it directly30descendants
- K092010PC Ecg, Model SE-1010Edan Instruments, Inc. · 2009 · 2 generations on18descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K951130 | Cardiosoft/Cardiosys | Marquette Electronics, Inc. | 1996 | — |
| +1 | K973403 | Cardiosmart ST | Marquette Medical Systems, Inc. | 1998 | — |
| +1 | 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 | — |
| +2 | 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 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? (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 512 Named without a submission number |
What descends from it? (35)
See all 353 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?
- Of its descendants, K973403 (Marquette Medical Systems, Inc., 1998) has gone furthest, with 34 descendants of its own.
What is it indicated for?
CardioSoft / CardioSys are intended to be used in resting ECG, emergency- and stress-test departments to record, archive and disseminate ECG information.
They are intended to be used by trained operators under the direct supervision of a physician when ECG records are required in the judgement of a physician.
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/K951130 · printed Nov 4, 2026
Cite this page
510(k) Report. “K951130: Cardiosoft/Cardiosys.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K951130
Report an extraction error
Are you the manufacturer?
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