510(k) · Cleared
ClearedRadianalyzer Xpress
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 Oct 9, 2009 as substantially equivalent to K042628 (Radi Medical Systems AB, 2005) and 1 other predicate after an 87-day review. Its family tree reaches back 5 generations to 2001. 25 later devices descend from it.
- Decided
- Oct 9, 2009
- Review
- 87 days
- Class
- Class II
- Product code
- DQK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K003122 (2001). 8 ancestors in all, the oldest K002067 (2001). 25 later devices descend from it, 8 citing it directly.
- Root · 5 generations backK003122 Smartflow, Model Sfip 2000Florence Medical, Ltd. · 2001
- 4 generations backK012947 SmartflowFlorence Medical, Ltd. · 2001
- 3 generations backK020127 Smartflow Pulse Transmission CoefficientFlorence Medical, Ltd. · 2002
- 2 generations backK022188 Radianalyzer, Model 12710Radi Medical Systems AB · 2002
- 1 generation backK042628 Modification to: Radianalyzer, Model 12711Radi Medical Systems AB · 2005
- This deviceK092105 Radianalyzer XpressRadi Medical Systems AB · 2009
- Descendant · cites it directly · 10 of its ownK151613 iLab Polaris Multi-Modality Guidance SystemBoston Scientific Corporation · 2015
- Descendant · 2 generations on · 8 of its ownK191008 iLab Polaris Multi-Modality Guidance SystemBoston Scientific Corporation · 2019 · Recalled
- Descendant · 3 generations on · 6 of its ownK201178 iLab Polaris Multi-Modality Guidance SystemBoston Scientific · 2020
- Descendant · cites it directly · 5 of its ownK123984 Quantien Measurement SystemRadi Medical Systems AB · 2013
- Descendant · 4 generations on · 4 of its ownK210889 iLab Polaris Multi-Modality Guidance SystemBoston Scientific Corporation · 2021
Showing 5 of 25 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 25 · See all- K151613iLab Polaris Multi-Modality Guidance SystemBoston Scientific Corporation · 2015 · cites it directly10descendants
- K191008iLab Polaris Multi-Modality Guidance SystemBoston Scientific Corporation · 2019 · 2 generations on8descendants
- K201178iLab Polaris Multi-Modality Guidance SystemBoston Scientific · 2020 · 3 generations on6descendants
- K123984Quantien Measurement SystemRadi Medical Systems AB · 2013 · cites it directly5descendants
- K210889iLab Polaris Multi-Modality Guidance SystemBoston Scientific Corporation · 2021 · 4 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K003122 | Smartflow, Model Sfip 2000 | Florence Medical, Ltd. | 2001 | — |
| −4 | K012947 | Smartflow | Florence Medical, Ltd. | 2001 | — |
| −3 | K020127 | Smartflow Pulse Transmission Coefficient | Florence Medical, Ltd. | 2002 | — |
| −2 | K022188 | Radianalyzer, Model 12710 | Radi Medical Systems AB | 2002 | — |
| −1 | K042628 | Modification to: Radianalyzer, Model 12711 | Radi Medical Systems AB | 2005 | — |
| 0 (this device) | K092105 | Radianalyzer Xpress | Radi Medical Systems AB | 2009 | — |
| +1 | K151613 | iLab Polaris Multi-Modality Guidance System | Boston Scientific Corporation | 2015 | — |
| +2 | K191008 | iLab Polaris Multi-Modality Guidance System | Boston Scientific Corporation | 2019 | 1 |
| +3 | K201178 | iLab Polaris Multi-Modality Guidance System | Boston Scientific | 2020 | — |
| +1 | K123984 | Quantien Measurement System | Radi Medical Systems AB | 2013 | — |
| +4 | K210889 | iLab Polaris Multi-Modality Guidance System | Boston Scientific Corporation | 2021 | — |
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 |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K042628 | Modification to: Radianalyzer, Model 12711Summary page 1…rogrammable Diagnostic Computer §870.1425 Blood pressure computer § 870.1110 Predicate Device Names: RadiAnalyzer® Xpress (K042628) RadiView® (KO13943) Device Description: RadiAnalyzer® Xpress is a diagnostic computer desig… | 2005 |
| * | K013943 | Radianalyzer, Model 12710, Radiview (PC-Software Accessory), Model 12720 | 2001 |
What descends from it? (25)
See all 258 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K151613 | iLab Polaris Multi-Modality Guidance System | 2015 | 10 |
| K123984 | Quantien Measurement System | 2013 | 5 |
| K141615 | Endophys Blood Pressure Monitor | 2015 | 2 |
| K111201 | C7 XR Imaging System | 2011 | 2 |
| K201881 | CoroFlow Cardiovascular System | 2020 | 1 |
| K252238 | CoroFlow Cardiovascular System | 2025 | 0 |
| K190852 | Zurich Pressure Guidewire System Model 100 | 2019 | 0 |
| K111854 | AO Usb Receiver, WI-Box, WI-Box Psu Kit, WI-Box Xpress Cable, PW Usb Receiver | 2011 | 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 8 years and passes through 2 companies; a new generation was cleared every 8 months on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K151613 (Boston Scientific Corporation, 2015) has gone furthest, with 10 descendants 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. 2009, 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?
RadiAnalyzer® Xpress is indicated to provide hemodynaimic information for use in the diagnosis and treatment of patients that undeigo measurement of physiological parameters with PressureWire®.
RadiAnalyzer® Xpress is intended for use in catheterization and related cardiovascular specialty laboratories to compute, and display various physiological and blood flow 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/K092105 · printed Nov 5, 2026
Cite this page
510(k) Report. “K092105: Radianalyzer Xpress.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K092105
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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