510(k) · Cleared
ClearedQUANTIEN Measurement System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
St. Jude Medical (Now Abbott Medical) · DQK Computer, Diagnostic, Programmable
Cleared on Feb 28, 2019 as substantially equivalent to K172182 (St. Jude Medical (Now Part of the Abbott Medical), 2017) and 1 other predicate after a 113-day review. Its family tree reaches back 10 generations to 1995. 3 later devices descend from it.
- Decided
- Feb 28, 2019
- Review
- 113 days
- Class
- Class II
- Product code
- DQK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to K934139 (1995). 59 ancestors in all, the oldest K823434 (1982). 3 later devices descend from it, 3 citing it directly.
- Root · 10 generations backK934139 Tomtec Echo-ViewTomtec Tomographic Technologies GmbH · 1995
- 6 generations between
- 3 generations backK111706 Volcano S5IINTRAVASCULAR Imaging and Pressure SystemVolcano Corporation · 2011 · Recalled
- 2 generations backK123898 Volcano S5/S5I Intravascular Ultrasound Imaging and Pressure SystemVolcano Corporation · 2013 · Recalled
- 1 generation backK133323 Volcano Ifr ModalityVolcano Corporation · 2014
- This deviceK183099 QUANTIEN Measurement SystemSt. Jude Medical (Now Abbott Medical) · 2019
- Descendant · cites it directly · 1 of its ownK201881 CoroFlow Cardiovascular SystemCoroventis Research AB · 2020
- Descendant · cites it directly · 0 of its ownK252238 CoroFlow Cardiovascular SystemCoroventis Research AB · 2025
- Descendant · cites it directly · 0 of its ownK220243 Ultiri Measurement SystemAbbott Medical · 2022
Show all 10 generations
- Root · 10 generations backK934139 Tomtec Echo-ViewTomtec Tomographic Technologies GmbH · 1995
- 9 generations backK993398 Echo View, Easy View, Omni ViewTomtec Imaging Systems GmbH · 1999
- 8 generations backK022824 Echo-View 5.X, Easy-View 2.X, Omni View 2.X, Cardio-View 1.X, LV…Tomtec Imaging Systems GmbH · 2002
- 7 generations backK042188 Volcano Therapeutics, Inc. Volcano Ivus SystemVolcano Therapeutics, Inc. · 2004
- 6 generations backK051337 Eagle Eye Gold Ivus Imaging Catheter, Model 85900/859XX; Volcano…Volcano Corporation · 2005
- 5 generations backK071554 Volcano S5/S5I Intravascular Imaging and Pressure SystemVolcano Corporation · 2008 · Recalled
- 4 generations backK082229 S5/S5I Series Intravascular Imaging and Pressure System, Combomap…Volcano Corporation · 2008 · Recalled
- 3 generations backK111706 Volcano S5IINTRAVASCULAR Imaging and Pressure SystemVolcano Corporation · 2011 · Recalled
- 2 generations backK123898 Volcano S5/S5I Intravascular Ultrasound Imaging and Pressure SystemVolcano Corporation · 2013 · Recalled
- 1 generation backK133323 Volcano Ifr ModalityVolcano Corporation · 2014
- This deviceK183099 QUANTIEN Measurement SystemSt. Jude Medical (Now Abbott Medical) · 2019
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K934139 | Tomtec Echo-View | Tomtec Tomographic Technologies GmbH | 1995 | — |
| −9 | K993398 | Echo View, Easy View, Omni View | Tomtec Imaging Systems GmbH | 1999 | — |
| −8 | 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 | — |
| −7 | K042188 | Volcano Therapeutics, Inc. Volcano Ivus System | Volcano Therapeutics, Inc. | 2004 | — |
| −6 | K051337 | Eagle Eye Gold Ivus Imaging Catheter, Model 85900/859XX; Volcano VH-Ivus… | Volcano Corporation | 2005 | — |
| −5 | K071554 | Volcano S5/S5I Intravascular Imaging and Pressure System | Volcano Corporation | 2008 | 2 |
| −4 | K082229 | S5/S5I Series Intravascular Imaging and Pressure System, Combomap Pressure and… | Volcano Corporation | 2008 | 3 |
| −3 | K111706 | Volcano S5IINTRAVASCULAR Imaging and Pressure System | Volcano Corporation | 2011 | 1 |
| −2 | K123898 | Volcano S5/S5I Intravascular Ultrasound Imaging and Pressure System | Volcano Corporation | 2013 | 10 |
| −1 | K133323 | Volcano Ifr Modality | Volcano Corporation | 2014 | — |
| 0 (this device) | K183099 | QUANTIEN Measurement System | St. Jude Medical (Now Abbott Medical) | 2019 | — |
| +1 | K201881 | CoroFlow Cardiovascular System | Coroventis Research AB | 2020 | — |
| +1 | K252238 | CoroFlow Cardiovascular System | Coroventis Research AB | 2025 | — |
| +1 | K220243 | Ultiri Measurement System | Abbott Medical | 2022 | — |
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 |
|---|---|---|
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 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 26.7 · 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 |
|---|---|---|---|
| * | K172182 | QUANTIEN Measurement SystemSummary page 4…ic computer Number and Name 21 CFR 810.1110, Blood pressure computer Device Class II Primary: QUANTIEN™ Measurement System (K172182), cleared 18 August 2017 Predicate Device Secondary: Volcano iFR® Modality (K133323), cleared 14 March 2… | 2017 |
| * | K133323 | Volcano Ifr ModalitySummary page 4…Primary: QUANTIEN™ Measurement System (K172182), cleared 18 August 2017 Predicate Device Secondary: Volcano iFR® Modality (K133323), cleared 14 March 2014 The QUANTIEN™ Measurement System is a diagnostic computer designed to record,… | 2014 |
What descends from it? (3)
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?
- The line of descent spans 24 years and passes through 5 companies; a new generation was cleared every 2.4 years on median.
- 6 of the 59 ancestors have a recall of any class.
- Of its descendants, K201881 (Coroventis Research AB, 2020) has gone furthest, with 1 descendant of its own.
How does its category compare?
All DQK devicesDQK Computer, Diagnostic, Programmable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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?
The QUANTIEN™ Measurement System is indicated to provide hemodynamic information for use in the diagnosis and treatment of coronary or peripheral artery disease.
The QUANTIEN measurement system is intended for use in the catheterization and related cardiovascular specialty laboratories to compute, and display various physiological parameters based on the output from one or more electrodes, transducers, or measuring devices.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K183099 · printed Nov 4, 2026
Cite this page
510(k) Report. “K183099: QUANTIEN Measurement System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K183099
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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