510(k) · Cleared
ClearedCardioview 3000 Software
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Micromedical, Inc. · LOS (no longer in FDA’s product-code list)
Cleared on Sep 8, 1998 after a 293-day review. The FDA summary names its predicate without a number. 11 later devices descend from it.
- Decided
- Sep 8, 1998
- Review
- 293 days
- Product code
- LOS
- Recalls
- None
- Predicates
- 0
11 later devices descend from it, 2 citing it directly.
- This deviceK974352 Cardioview 3000 SoftwareMicromedical, Inc. · 1998
- Descendant · cites it directly · 9 of its ownK083749 CARDIOVIEW32 Review ModuleQrs Diagnostic, LLC · 2009
- Descendant · 2 generations on · 3 of its ownK133988 Tempus Pro Extended FeaturesRemote Diagnostic Technologies, Ltd. · 2014
- Descendant · 3 generations on · 2 of its ownK170567 Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd. · 2017
- Descendant · 2 generations on · 2 of its ownK102378 Vectraplexecg System with VectraplexamiVectracor, Inc. · 2011
- Descendant · 3 generations on · 1 of its ownK173952 Universal SmartECGVectracor, Inc. · 2018
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K083749CARDIOVIEW32 Review ModuleQrs Diagnostic, LLC · 2009 · cites it directly9descendants
- K133988Tempus Pro Extended FeaturesRemote Diagnostic Technologies, Ltd. · 2014 · 2 generations on3descendants
- K170567Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd. · 2017 · 3 generations on2descendants
- K102378Vectraplexecg System with VectraplexamiVectracor, Inc. · 2011 · 2 generations on2descendants
- K173952Universal SmartECGVectracor, Inc. · 2018 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K974352 | Cardioview 3000 Software | Micromedical, Inc. | 1998 | — |
| +1 | K083749 | CARDIOVIEW32 Review Module | Qrs Diagnostic, LLC | 2009 | — |
| +2 | K133988 | Tempus Pro Extended Features | Remote Diagnostic Technologies, Ltd. | 2014 | — |
| +3 | K170567 | Tempus Pro Patient Monitor | Remote Diagnostic Technologies, Ltd. | 2017 | — |
| +2 | K102378 | Vectraplexecg System with Vectraplexami | Vectracor, Inc. | 2011 | — |
| +3 | K173952 | Universal SmartECG | Vectracor, Inc. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 2 | 0 |
| 2011 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2020 | 1 | 0 |
| 2024 | 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 |
|---|---|---|---|
| * | — | MAX 1 Exercise Testing System Named without a submission number |
What descends from it? (11)
See all 112 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, K083749 (Qrs Diagnostic, LLC, 2009) has gone furthest, with 9 descendants of its own.
What is it indicated for?
CARDIOVIEW™ 3000 interpretive software is a Windows-based program intended to interpret electrocardiograms. CARDIOVIEW™ 3000 interpretive software receives, displays and stores a single or standard 12-lead simultaneous ECG recording, which is transmitted either locally or transtelephonically from a Micromedical™ ECG monitor using a proprietary digital data transmission protocol. The device contains proprietary software algorithms to receive, store, analyze, and interpret the ECG signal.
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/K974352 · printed Nov 4, 2026
Cite this page
510(k) Report. “K974352: Cardioview 3000 Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K974352
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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