510(k) · Cleared
ClearedCoroFlow Cardiovascular System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Coroventis Research AB · DQK Computer, Diagnostic, Programmable
Cleared on Nov 13, 2020 as substantially equivalent to K183099 (St. Jude Medical (Now Abbott Medical), 2019) and 1 other predicate after a 129-day review. Its family tree reaches back 11 generations to 1995. 1 later device descends from it.
- Decided
- Nov 13, 2020
- Review
- 129 days
- Class
- Class II
- Product code
- DQK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 11 generations to K934139 (1995). 60 ancestors in all, the oldest K823434 (1982). 1 later device descends from it, 1 citing it directly.
- Root · 11 generations backK934139 Tomtec Echo-ViewTomtec Tomographic Technologies GmbH · 1995
- 7 generations between
- 3 generations backK123898 Volcano S5/S5I Intravascular Ultrasound Imaging and Pressure SystemVolcano Corporation · 2013 · Recalled
- 2 generations backK133323 Volcano Ifr ModalityVolcano Corporation · 2014
- 1 generation backK183099 QUANTIEN Measurement SystemSt. Jude Medical (Now Abbott Medical) · 2019
- This deviceK201881 CoroFlow Cardiovascular SystemCoroventis Research AB · 2020
- Descendant · cites it directly · 0 of its ownK252238 CoroFlow Cardiovascular SystemCoroventis Research AB · 2025
Show all 11 generations
- Root · 11 generations backK934139 Tomtec Echo-ViewTomtec Tomographic Technologies GmbH · 1995
- 10 generations backK993398 Echo View, Easy View, Omni ViewTomtec Imaging Systems GmbH · 1999
- 9 generations backK022824 Echo-View 5.X, Easy-View 2.X, Omni View 2.X, Cardio-View 1.X, LV…Tomtec Imaging Systems GmbH · 2002
- 8 generations backK042188 Volcano Therapeutics, Inc. Volcano Ivus SystemVolcano Therapeutics, Inc. · 2004
- 7 generations backK051337 Eagle Eye Gold Ivus Imaging Catheter, Model 85900/859XX; Volcano…Volcano Corporation · 2005
- 6 generations backK071554 Volcano S5/S5I Intravascular Imaging and Pressure SystemVolcano Corporation · 2008 · Recalled
- 5 generations backK082229 S5/S5I Series Intravascular Imaging and Pressure System, Combomap…Volcano Corporation · 2008 · Recalled
- 4 generations backK111706 Volcano S5IINTRAVASCULAR Imaging and Pressure SystemVolcano Corporation · 2011 · Recalled
- 3 generations backK123898 Volcano S5/S5I Intravascular Ultrasound Imaging and Pressure SystemVolcano Corporation · 2013 · Recalled
- 2 generations backK133323 Volcano Ifr ModalityVolcano Corporation · 2014
- 1 generation backK183099 QUANTIEN Measurement SystemSt. Jude Medical (Now Abbott Medical) · 2019
- This deviceK201881 CoroFlow Cardiovascular SystemCoroventis Research AB · 2020
Most influential descendants
Showing 1 of 1 · See all- K252238CoroFlow Cardiovascular SystemCoroventis Research AB · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K934139 | Tomtec Echo-View | Tomtec Tomographic Technologies GmbH | 1995 | — |
| −10 | K993398 | Echo View, Easy View, Omni View | Tomtec Imaging Systems GmbH | 1999 | — |
| −9 | K022824 | Echo-View 5.X, Easy-View 2.X, Omni View 2.X, Cardio-View 1.X, LV Analysis 1.X… | Tomtec Imaging Systems GmbH | 2002 | — |
| −8 | K042188 | Volcano Therapeutics, Inc. Volcano Ivus System | Volcano Therapeutics, Inc. | 2004 | — |
| −7 | K051337 | Eagle Eye Gold Ivus Imaging Catheter, Model 85900/859XX; Volcano VH-Ivus… | Volcano Corporation | 2005 | — |
| −6 | K071554 | Volcano S5/S5I Intravascular Imaging and Pressure System | Volcano Corporation | 2008 | 2 |
| −5 | K082229 | S5/S5I Series Intravascular Imaging and Pressure System, Combomap Pressure and… | Volcano Corporation | 2008 | 3 |
| −4 | K111706 | Volcano S5IINTRAVASCULAR Imaging and Pressure System | Volcano Corporation | 2011 | 1 |
| −3 | K123898 | Volcano S5/S5I Intravascular Ultrasound Imaging and Pressure System | Volcano Corporation | 2013 | 10 |
| −2 | K133323 | Volcano Ifr Modality | Volcano Corporation | 2014 | — |
| −1 | K183099 | QUANTIEN Measurement System | St. Jude Medical (Now Abbott Medical) | 2019 | — |
| 0 (this device) | K201881 | CoroFlow Cardiovascular System | Coroventis Research AB | 2020 | — |
| +1 | K252238 | CoroFlow Cardiovascular System | Coroventis Research AB | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1986 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 5 | 0 |
| 1993 | 3 | 0 |
| 1994 | 3 | 0 |
| 1995 | 2 | 0 |
| 1996 | 3 | 0 |
| 1997 | 3 | 0 |
| 1998 | 3 | 0 |
| 2000 | 2 | 0 |
| 2001 | 4 | 0 |
| 2002 | 4 | 0 |
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
| 2005 | 4 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2013 | 1 | 0 |
| 2017 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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 DQK? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DQK device
- #1 K213682 HemoSphere Advanced Monitor, HemoSphere…score 26.6 · 28 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K183099 | QUANTIEN Measurement SystemSummary page 4…21 CFR 870.1425, Programmable diagnostic computer and name: Device II classification: Predicate device(s): Primary: QUANTIEN™ Measurement System (K183099) with Software Version 1.12.1, cleared 28 February 2019. Secondary: RadiAnalyzer… | 2019 |
| * | K092105 | Radianalyzer XpressSummary page 4…N™ Measurement System (K183099) with Software Version 1.12.1, cleared 28 February 2019. Secondary: RadiAnalyzer® Xpress (K092105) with accessory software RadiView® and Physiomon™, cleared 9 October 2009. Device description: CoroF… | 2009 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K252238 | CoroFlow Cardiovascular System | 2025 | 0 |
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 25 years and passes through 6 companies; a new generation was cleared every 2.1 years on median.
- 6 of the 60 ancestors have a recall of any class.
- Of its descendants, K252238 (Coroventis Research AB, 2025) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K183099.
How does its category compare?
All DQK devicesDQK Computer, Diagnostic, Programmable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · DQK
23so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · DQK
95in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQK
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DQK
433in 2025
MAUDE reports naming product code DQK, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 13 | 83 | 4 | 18 |
| 2008 | 4 | 70 | 1 | 34 |
| 2009 | 12 | 93 | 2 | 40 |
| 2010 | 9 | 64 | 3 | 49 |
| 2011 | 12 | 69 | 2 | 55 |
| 2012 | 7 | 74 | 3 | 129 |
| 2013 | 13 | 68 | 1 | 180 |
| 2014 | 9 | 90 | 4 | 115 |
| 2015 | 7 | 125 | 2 | 131 |
| 2016 | 15 | 190 | 0 | 340 |
| 2017 | 7 | 146 | 2 | 252 |
| 2018 | 14 | 150 | 6 | 261 |
| 2019 | 15 | 113 | 1 | 218 |
| 2020 | 16 | 123 | 1 | 215 |
| 2021 | 16 | 132 | 1 | 351 |
| 2022 | 19 | 136 | 2 | 319 |
| 2023 | 21 | 133 | 2 | 340 |
| 2024 | 13 | 100 | 24 | 557 |
| 2025 | 22 | 95 | 1 | 433 |
| 2026 | 23 | 151 | 2 | — |
What is it indicated for?
CoroFlow is indicated to provide hemodynamic information for use in the diagnosis of patients with cardiovascular diseases.
CoroFlow is intended for use in catheterization and related cardiovascular specialty laboratories to compute and display various physiological parameters based on the output from one or more measuring devices.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K201881 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201881: CoroFlow Cardiovascular System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201881
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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