510(k) · Cleared
ClearedCardiosmart ST
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Marquette Medical Systems, Inc. · LOS (no longer in FDA’s product-code list)
Cleared on Mar 12, 1998 as substantially equivalent to K950989 (Hellige GmbH, 1996) and 2 other predicates after a 184-day review. Its family tree reaches back 1 generation to 1991. 34 later devices descend from it.
- Decided
- Mar 12, 1998
- Review
- 184 days
- Product code
- LOS
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K903644 (1991). 3 ancestors in all. 34 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK903644 Series 1500 12-Lead Analysis OptionMarquette Electronics, Inc. · 1991
- This deviceK973403 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 · 2 generations on · 30 of its ownK031561 Cardiosoft/Case Cardiac Testing SystemGe Medical Systems Information Technologies · 2003
- Descendant · 3 generations on · 18 of its ownK092010 PC Ecg, Model SE-1010Edan Instruments, Inc. · 2009
- Descendant · 3 generations on · 13 of its ownK102854 PC ECGEdan Instruments, Inc. · 2010
Showing 5 of 34 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 34 · See all- 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 · 2 generations on30descendants
- K092010PC Ecg, Model SE-1010Edan Instruments, Inc. · 2009 · 3 generations on18descendants
- K102854PC ECGEdan Instruments, Inc. · 2010 · 3 generations on13descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K903644 | Series 1500 12-Lead Analysis Option | Marquette Electronics, Inc. | 1991 | — |
| 0 (this device) | 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 | — |
| +2 | K031561 | Cardiosoft/Case Cardiac Testing System | Ge Medical Systems Information Technologies | 2003 | — |
| +3 | K092010 | PC Ecg, Model SE-1010 | Edan Instruments, Inc. | 2009 | — |
| +3 | K102854 | PC ECG | Edan Instruments, Inc. | 2010 | — |
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 |
|---|---|---|
| 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? (3)
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 |
|---|---|---|---|
| * | K950989 | CardiosmartSummary page 1…ices The CardioSmart ST, is substantially equivalent to devices already in legal commercial distribution. These predicate devices include: Marquette Hellige CardioSmart K950989 Marquette Hellige CardioSys K951130 Marquette Responder 1500 K903644 Device Description CardioSmart ST is a portable ECG data ac… | 1996 |
| * | K951130 | Cardiosoft/CardiosysSummary page 1…ially equivalent to devices already in legal commercial distribution. These predicate devices include: Marquette Hellige CardioSmart K950989 Marquette Hellige CardioSys K951130 Marquette Responder 1500 K903644 Device Description CardioSmart ST is a portable ECG data acquisition and recording system desig… | 1996 |
| * | K903644 | Series 1500 12-Lead Analysis OptionSummary page 1…dy in legal commercial distribution. These predicate devices include: Marquette Hellige CardioSmart K950989 Marquette Hellige CardioSys K951130 Marquette Responder 1500 K903644 Device Description CardioSmart ST is a portable ECG data acquisition and recording system designed and manufactured by Marquette… | 1991 |
What descends from it? (34)
See all 342 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?
- None of the 3 ancestors has a recall.
- Of its descendants, K991014 (General Electric Medical Systems Information Techn, 1999) has gone furthest, with 33 descendants of its own.
What is it indicated for?
CardioSmart ST is an ECG data acquisition and recording system designed and manufactured by Marquette Hellige GmbH. CardioSmart ST is intended to be used for resting ECG and stress test ECG and for recording ECG in real-time without arrhythmia detection. It is intended to be used by trained operators when ECG records are required in the judgement of a physician. ECG may be interpreted by optionally available analysis program. CardioSmart ST offers no…
Read the full statement (121 words)
CardioSmart ST is an ECG data acquisition and recording system designed and manufactured by Marquette Hellige GmbH.
CardioSmart ST is intended to be used for resting ECG and stress test ECG and for recording ECG in real-time without arrhythmia detection. It is intended to be used by trained operators when ECG records are required in the judgement of a physician.
ECG may be interpreted by optionally available analysis program. CardioSmart ST offers no diagnostic opinion to the user. Instead, it provides interpretive statements for which the physician renders his/her own medical opinion.
CardioSmart ST is not intended for use as a vital signs physiological monitor.
CardioSmart ST is not designed for intracardial use.
CardioSmart ST 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/K973403 · printed Nov 4, 2026
Cite this page
510(k) Report. “K973403: Cardiosmart ST.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K973403
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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