510(k) · Cleared
ClearedAcute Cardiac Ischemia Time-Insensitive Predictive Instrument (Aci-Tipi) Option
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 Feb 6, 1998 after an 88-day review. The FDA summary names its predicate without a number. 72 later devices descend from it.
- Decided
- Feb 6, 1998
- Review
- 88 days
- Product code
- LOS
- Recalls
- None
- Predicates
- 0
72 later devices descend from it, 1 citing it directly.
- This deviceK974199 Acute Cardiac Ischemia Time-Insensitive Predictive Instrument…Marquette Medical Systems, Inc. · 1998
- Descendant · cites it directly · 71 of its ownK014108 Mac 5000 Ecg Analysis SystemGeneral Electric Medical Systems Information Techn · 2002
- Descendant · 2 generations on · 32 of its ownK091513 Smart Ecg Series Electrocardiograph, Models SE-3, SE-300A and 300B…Edan Instruments, Inc. · 2009 · Recalled
- Descendant · 2 generations on · 31 of its ownK033492 Modification to Mac 5000 Ecg Analysis SystemGe Medical Systems Information Technologies · 2003
- Descendant · 3 generations on · 30 of its ownK042177 Modification to Mac 5000 Ecg Analysis SystemGe Medical Systems Information Technologies · 2004
- Descendant · 4 generations on · 21 of its ownK060833 12SL Ecg Analysis ProgramGe Medical Systems Information Technologies · 2006
Showing 5 of 72 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 72 · See all- K014108Mac 5000 Ecg Analysis SystemGeneral Electric Medical Systems Information Techn · 2002 · cites it directly71descendants
- K091513Smart Ecg Series Electrocardiograph, Models SE-3, SE-300A and 300B, SE-6, SE-600, SE-12…Edan Instruments, Inc. · 2009 · 2 generations on32descendants
- K033492Modification to Mac 5000 Ecg Analysis SystemGe Medical Systems Information Technologies · 2003 · 2 generations on31descendants
- K042177Modification to Mac 5000 Ecg Analysis SystemGe Medical Systems Information Technologies · 2004 · 3 generations on30descendants
- K06083312SL Ecg Analysis ProgramGe Medical Systems Information Technologies · 2006 · 4 generations on21descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K974199 | Acute Cardiac Ischemia Time-Insensitive Predictive Instrument (Aci-Tipi) Option | Marquette Medical Systems, Inc. | 1998 | — |
| +1 | K014108 | Mac 5000 Ecg Analysis System | General Electric Medical Systems Information Techn | 2002 | — |
| +2 | K091513 | Smart Ecg Series Electrocardiograph, Models SE-3, SE-300A and 300B, SE-6… | Edan Instruments, Inc. | 2009 | 1 |
| +2 | K033492 | Modification to Mac 5000 Ecg Analysis System | Ge Medical Systems Information Technologies | 2003 | — |
| +3 | K042177 | Modification to Mac 5000 Ecg Analysis System | Ge Medical Systems Information Technologies | 2004 | — |
| +4 | K060833 | 12SL Ecg Analysis Program | Ge Medical Systems Information Technologies | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2006 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 4 | 0 |
| 2011 | 6 | 0 |
| 2012 | 3 | 0 |
| 2013 | 5 | 0 |
| 2014 | 7 | 0 |
| 2015 | 4 | 0 |
| 2016 | 5 | 0 |
| 2017 | 4 | 0 |
| 2018 | 5 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 4 | 0 |
| 2023 | 2 | 0 |
| 2024 | 6 | 0 |
| 2025 | 2 | 0 |
| 2026 | 2 | 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 |
|---|---|---|---|
| * | — | Hewlett-Packard Model 1791A ACI-TIPI Named without a submission number |
What descends from it? (72)
See all 721 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K014108 | Mac 5000 Ecg Analysis System | 2002 | 71 |
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, K014108 (General Electric Medical Systems Information Techn, 2002) has gone furthest, with 71 descendants of its own.
What is it indicated for?
Acute Cardiac Ischemia Time-Insensitive Predictive Instrument (ACI-TIPI) Option is intended to be used in a hospital or clinic environment by competent health professionals. ACI-TIPI utilizes recorded ECG data along with patient demographic and chest pain status to produce a numerical score which is the predicted probability of acute cardiac ischemia. Like any computer-assisted ECG interpretation program, the Marquette ACI-TIPI evaluation and probability…
Read the full statement (106 words)
Acute Cardiac Ischemia Time-Insensitive Predictive Instrument (ACI-TIPI) Option is intended to be used in a hospital or clinic environment by competent health professionals. ACI-TIPI utilizes recorded ECG data along with patient demographic and chest pain status to produce a numerical score which is the predicted probability of acute cardiac ischemia. Like any computer-assisted ECG interpretation program, the Marquette ACI-TIPI evaluation and probability score is intended to supplement, not substitue for the physician’s decision process. It should be used in conjunction with knowledge of the patient's history, the results of a physical examination, the ECG tracing, and other clinical findings.
ACI-TIPI is intended for adult patient populations.
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/K974199 · printed Nov 6, 2026
Cite this page
510(k) Report. “K974199: Acute Cardiac Ischemia Time-Insensitive Predictive Instrument (Aci-Tipi) Option.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K974199
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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