510(k) · Cleared
ClearedCARDIOVIEW32 Review Module
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Qrs Diagnostic, LLC · LOS (no longer in FDA’s product-code list)
Cleared on Mar 10, 2009 as substantially equivalent to K974352 (Micromedical, Inc., 1998) after an 83-day review. Its family tree reaches back 1 generation to 1998. 9 later devices descend from it.
- Decided
- Mar 10, 2009
- Review
- 83 days
- Product code
- LOS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K974352 (1998). 9 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK974352 Cardioview 3000 SoftwareMicromedical, Inc. · 1998
- This deviceK083749 CARDIOVIEW32 Review ModuleQrs Diagnostic, LLC · 2009
- Descendant · cites it directly · 3 of its ownK133988 Tempus Pro Extended FeaturesRemote Diagnostic Technologies, Ltd. · 2014
- Descendant · 2 generations on · 2 of its ownK170567 Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd. · 2017
- Descendant · cites it directly · 2 of its ownK102378 Vectraplexecg System with VectraplexamiVectracor, Inc. · 2011
- Descendant · 2 generations on · 1 of its ownK173952 Universal SmartECGVectracor, Inc. · 2018
- Descendant · 3 generations on · 1 of its ownK173768 Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd. · 2018
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K133988Tempus Pro Extended FeaturesRemote Diagnostic Technologies, Ltd. · 2014 · cites it directly3descendants
- K170567Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd. · 2017 · 2 generations on2descendants
- K102378Vectraplexecg System with VectraplexamiVectracor, Inc. · 2011 · cites it directly2descendants
- K173952Universal SmartECGVectracor, Inc. · 2018 · 2 generations on1descendant
- K173768Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd. · 2018 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K974352 | Cardioview 3000 Software | Micromedical, Inc. | 1998 | — |
| 0 (this device) | K083749 | CARDIOVIEW32 Review Module | Qrs Diagnostic, LLC | 2009 | — |
| +1 | K133988 | Tempus Pro Extended Features | Remote Diagnostic Technologies, Ltd. | 2014 | — |
| +2 | K170567 | Tempus Pro Patient Monitor | Remote Diagnostic Technologies, Ltd. | 2017 | — |
| +1 | K102378 | Vectraplexecg System with Vectraplexami | Vectracor, Inc. | 2011 | — |
| +2 | K173952 | Universal SmartECG | Vectracor, Inc. | 2018 | — |
| +3 | K173768 | Tempus Pro Patient Monitor | Remote Diagnostic Technologies, Ltd. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K974352 | Cardioview 3000 SoftwareSummary page 1…Date Predicate Cleared CardioView MicroMedical, ECG Analysis K974352 9/8/1998 3000 Inc Device Description: Indications for Use CardioView32 Review Module is a Window'… | 1998 |
What descends from it? (9)
3 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?
What is it indicated for?
CardioView32 Review Module is a Window's based program intended to be called from a host application/database in a hospital or in a Physician's Office. CardioView32 Review Module receives, analyzes, displays, stores and prints ECG *.scp files generated from a standard 12-lead ECG recording. CardioView 32 Review Module provides interpretive statements for which the physician renders his/her own medical opinion.
Patient Population: Male/Female, Adults
Environment of Use: Hospital and Clinic
Prescription Device by a Physician
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083749 · printed Nov 5, 2026
Cite this page
510(k) Report. “K083749: CARDIOVIEW32 Review Module.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K083749
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