510(k) · Cleared
ClearedModification to: Radianalyzer, Model 12711
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 Jan 19, 2005 as substantially equivalent to K022188 (Radi Medical Systems AB, 2002) after a 114-day review. Its family tree reaches back 4 generations to 2001. 26 later devices descend from it.
- Decided
- Jan 19, 2005
- Review
- 114 days
- Class
- Class II
- Product code
- DQK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K003122 (2001). 7 ancestors in all, the oldest K002067 (2001). 26 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK003122 Smartflow, Model Sfip 2000Florence Medical, Ltd. · 2001
- 3 generations backK012947 SmartflowFlorence Medical, Ltd. · 2001
- 2 generations backK020127 Smartflow Pulse Transmission CoefficientFlorence Medical, Ltd. · 2002
- 1 generation backK022188 Radianalyzer, Model 12710Radi Medical Systems AB · 2002
- This deviceK042628 Modification to: Radianalyzer, Model 12711Radi Medical Systems AB · 2005
- Descendant · cites it directly · 25 of its ownK092105 Radianalyzer XpressRadi Medical Systems AB · 2009
- Descendant · 2 generations on · 10 of its ownK151613 iLab Polaris Multi-Modality Guidance SystemBoston Scientific Corporation · 2015
- Descendant · 3 generations on · 8 of its ownK191008 iLab Polaris Multi-Modality Guidance SystemBoston Scientific Corporation · 2019 · Recalled
- Descendant · 4 generations on · 6 of its ownK201178 iLab Polaris Multi-Modality Guidance SystemBoston Scientific · 2020
- Descendant · 2 generations on · 5 of its ownK123984 Quantien Measurement SystemRadi Medical Systems AB · 2013
Showing 5 of 26 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 26 · See all- K092105Radianalyzer XpressRadi Medical Systems AB · 2009 · cites it directly25descendants
- K151613iLab Polaris Multi-Modality Guidance SystemBoston Scientific Corporation · 2015 · 2 generations on10descendants
- K191008iLab Polaris Multi-Modality Guidance SystemBoston Scientific Corporation · 2019 · 3 generations on8descendants
- K201178iLab Polaris Multi-Modality Guidance SystemBoston Scientific · 2020 · 4 generations on6descendants
- K123984Quantien Measurement SystemRadi Medical Systems AB · 2013 · 2 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K003122 | Smartflow, Model Sfip 2000 | Florence Medical, Ltd. | 2001 | — |
| −3 | K012947 | Smartflow | Florence Medical, Ltd. | 2001 | — |
| −2 | K020127 | Smartflow Pulse Transmission Coefficient | Florence Medical, Ltd. | 2002 | — |
| −1 | K022188 | Radianalyzer, Model 12710 | Radi Medical Systems AB | 2002 | — |
| 0 (this device) | K042628 | Modification to: Radianalyzer, Model 12711 | Radi Medical Systems AB | 2005 | — |
| +1 | K092105 | Radianalyzer Xpress | Radi Medical Systems AB | 2009 | — |
| +2 | K151613 | iLab Polaris Multi-Modality Guidance System | Boston Scientific Corporation | 2015 | — |
| +3 | K191008 | iLab Polaris Multi-Modality Guidance System | Boston Scientific Corporation | 2019 | 1 |
| +4 | K201178 | iLab Polaris Multi-Modality Guidance System | Boston Scientific | 2020 | — |
| +2 | K123984 | Quantien Measurement System | Radi Medical Systems AB | 2013 | — |
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 |
|---|---|---|
| 2009 | 1 | 0 |
| 2011 | 2 | 0 |
| 2013 | 1 | 0 |
| 2015 | 3 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2019 | 4 | 0 |
| 2020 | 3 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 4 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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? (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 |
|---|---|---|---|
| * | K022188 | Radianalyzer, Model 12710Summary page 1…ammable diagnostic computer Classification Name: §870.1425, Programmable diagnostic computer Predicate Device: RADlAnalyzer®System 5 10(k) # 1(022188 Description of the Device: R-ADIAnalyzei-R® is a diagnostic computer designed to compute, record and display information, based… | 2002 |
What descends from it? (26)
See all 261 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K092105 | Radianalyzer Xpress | 2009 | 25 |
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 4 years and passes through 2 companies; a new generation was cleared every 8 months on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K092105 (Radi Medical Systems AB, 2009) has gone furthest, with 25 descendants of its own.
- 1 other device also cites its predicate K022188.
How does its category compare?
All DQK devicesDQK Computer, Diagnostic, Programmable: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
RadiAnalyzer® is indicated to provide hemodynamic information for use in the diagnosis and treatment of coronary or peripheral artery disease.
RadiAnalyzer® 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/K042628 · printed Nov 5, 2026
Cite this page
510(k) Report. “K042628: Modification to: Radianalyzer, Model 12711.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K042628
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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