510(k) · Cleared
ClearedQuantien Measurement System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Radi Medical Systems AB · DQK Computer, Diagnostic, Programmable
Cleared on Mar 28, 2013 as substantially equivalent to K092105 (Radi Medical Systems AB, 2009) after a 92-day review. Its family tree reaches back 6 generations to 2001. 5 later devices descend from it.
- Decided
- Mar 28, 2013
- Review
- 92 days
- Class
- Class II
- Product code
- DQK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K003122 (2001). 9 ancestors in all, the oldest K002067 (2001). 5 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK003122 Smartflow, Model Sfip 2000Florence Medical, Ltd. · 2001
- 5 generations backK012947 SmartflowFlorence Medical, Ltd. · 2001
- 4 generations backK020127 Smartflow Pulse Transmission CoefficientFlorence Medical, Ltd. · 2002
- 3 generations backK022188 Radianalyzer, Model 12710Radi Medical Systems AB · 2002
- 2 generations backK042628 Modification to: Radianalyzer, Model 12711Radi Medical Systems AB · 2005
- 1 generation backK092105 Radianalyzer XpressRadi Medical Systems AB · 2009
- This deviceK123984 Quantien Measurement SystemRadi Medical Systems AB · 2013
- Descendant · cites it directly · 4 of its ownK172182 QUANTIEN Measurement SystemSt. Jude Medical (Now Part of the Abbott Medical) · 2017
- Descendant · 2 generations on · 3 of its ownK183099 QUANTIEN Measurement SystemSt. Jude Medical (Now Abbott Medical) · 2019
- Descendant · 3 generations on · 1 of its ownK201881 CoroFlow Cardiovascular SystemCoroventis Research AB · 2020
- Descendant · 3 generations on · 0 of its ownK252238 CoroFlow Cardiovascular SystemCoroventis Research AB · 2025
- Descendant · 3 generations on · 0 of its ownK220243 Ultiri Measurement SystemAbbott Medical · 2022
Most influential descendants
Showing 5 of 5 · See all- K172182QUANTIEN Measurement SystemSt. Jude Medical (Now Part of the Abbott Medical) · 2017 · cites it directly4descendants
- K183099QUANTIEN Measurement SystemSt. Jude Medical (Now Abbott Medical) · 2019 · 2 generations on3descendants
- K201881CoroFlow Cardiovascular SystemCoroventis Research AB · 2020 · 3 generations on1descendant
- K252238CoroFlow Cardiovascular SystemCoroventis Research AB · 2025 · 3 generations on0descendants
- K220243Ultiri Measurement SystemAbbott Medical · 2022 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K003122 | Smartflow, Model Sfip 2000 | Florence Medical, Ltd. | 2001 | — |
| −5 | K012947 | Smartflow | Florence Medical, Ltd. | 2001 | — |
| −4 | K020127 | Smartflow Pulse Transmission Coefficient | Florence Medical, Ltd. | 2002 | — |
| −3 | K022188 | Radianalyzer, Model 12710 | Radi Medical Systems AB | 2002 | — |
| −2 | K042628 | Modification to: Radianalyzer, Model 12711 | Radi Medical Systems AB | 2005 | — |
| −1 | K092105 | Radianalyzer Xpress | Radi Medical Systems AB | 2009 | — |
| 0 (this device) | K123984 | Quantien Measurement System | Radi Medical Systems AB | 2013 | — |
| +1 | K172182 | QUANTIEN Measurement System | St. Jude Medical (Now Part of the Abbott Medical) | 2017 | — |
| +2 | K183099 | QUANTIEN Measurement System | St. Jude Medical (Now Abbott Medical) | 2019 | — |
| +3 | K201881 | CoroFlow Cardiovascular System | Coroventis Research AB | 2020 | — |
| +3 | K252238 | CoroFlow Cardiovascular System | Coroventis Research AB | 2025 | — |
| +3 | K220243 | Ultiri Measurement System | Abbott Medical | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 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 26.6 · 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? (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 |
|---|---|---|---|
| * | K092105 | Radianalyzer XpressSummary page 1…ame: QIJANTIEN Classification Name: §870.1425, Programmable diagnostic computer Predicate Device: RadiAnalyzer@ Xpress K092105 Description of the Device: QUANTIEN Measurement System~ is a diagnostic computer designed to record, compute, dis… | 2009 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K172182 | QUANTIEN Measurement System | 2017 | 4 |
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 12 years and passes through 2 companies; a new generation was cleared every 2.3 years on median.
- None of the 9 ancestors has a recall.
- Of its descendants, K172182 (St. Jude Medical (Now Part of the Abbott Medical), 2017) has gone furthest, with 4 descendants of its own.
- 7 other devices also cite its predicate K092105.
How does its category compare?
All DQK devicesDQK Computer, Diagnostic, Programmable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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?
QUANTIEN Measurement System is indicated to provide hemodynamic information for use in the diagnosis and treatment of coronary or peripheral artery disease. QUANTIEN Measurement System 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 electrodes, transducers, or measuring devices.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123984 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123984: Quantien Measurement System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123984
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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