510(k) · Cleared
ClearedFFRangio
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cathworks, Ltd. · QEK Angiographic Coronary Vascular Physiologic Simulation Software
Cleared on Dec 9, 2019 as substantially equivalent to K182149 (Cathworks, Ltd., 2018) after a 94-day review. Its family tree reaches back 4 generations to 2014.
- Decided
- Dec 9, 2019
- Review
- 94 days
- Class
- Class II
- Product code
- QEK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to DEN130045 (2014). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 QEK? 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 |
|---|---|---|---|
| * | K182149 | FFRangio SystemSummary page 4…15 Product Code: QEK Review Panel: Cardiovascular Class: II E. Predicate Device(s): K182149 FFRangio™ System F. Summary Device Description: FFRangio uses standard angiographic images that are retrieved from the X… | 2018 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 5 years and passes through 3 companies; a new generation was cleared every 1.1 years on median.
- None of the 4 ancestors has a recall.
How does its category compare?
All QEK devicesQEK Angiographic Coronary Vascular Physiologic Simulation Software: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · QEK
1in 2019
2026 to Oct 25, outlined.
Median 510(k) review, days · QEK
Too few QEK 510(k)s in any year since 2007 to give a median.
Recalls per year · QEK
No recall names QEK since 2007.
Adverse event reports per year · QEK
No MAUDE report names QEK since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
CathWorks FFRangio™ is a software device for the clinical quantitative and qualitative analysis of previously acquired angiography DICOM data for patients with coronary artery disease. It provides FFRangio™, a mathematically derived quantity, computed from simulated blood flow information obtained from a 3D computer model, generated from coronary angiography images. FFRangio™ analysis is intended to support the functional evaluation of coronary artery…
Read the full statement (117 words)
CathWorks FFRangio™ is a software device for the clinical quantitative and qualitative analysis of previously acquired angiography DICOM data for patients with coronary artery disease. It provides FFRangio™, a mathematically derived quantity, computed from simulated blood flow information obtained from a 3D computer model, generated from coronary angiography images. FFRangio™ analysis is intended to support the functional evaluation of coronary artery disease. The results of this analysis are provided as a supportive aid for qualified clinicians in the evaluation and assessment of coronary arteries physiology. The results of CathWorks FFRangio™ are intended to be used by qualified clinicians in conjunction with the patient’s clinical history, symptoms, and other diagnostic tests, as well as the clinician’s professional evaluation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K192442 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192442: FFRangio.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192442
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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