510(k) · Cleared
ClearedSmartflow
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Florence Medical, Ltd. · DQK Computer, Diagnostic, Programmable
Cleared on Oct 2, 2001 as substantially equivalent to K003122 (Florence Medical, Ltd., 2001) after a 28-day review. Its family tree reaches back 1 generation to 2001. 48 later devices descend from it.
- Decided
- Oct 2, 2001
- Review
- 28 days
- Class
- Class II
- Product code
- DQK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K003122 (2001). 48 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK003122 Smartflow, Model Sfip 2000Florence Medical, Ltd. · 2001
- This deviceK012947 SmartflowFlorence Medical, Ltd. · 2001
- Descendant · cites it directly · 47 of its ownK020127 Smartflow Pulse Transmission CoefficientFlorence Medical, Ltd. · 2002
- Descendant · 2 generations on · 46 of its ownK022188 Radianalyzer, Model 12710Radi Medical Systems AB · 2002
- Descendant · 3 generations on · 26 of its ownK042628 Modification to: Radianalyzer, Model 12711Radi Medical Systems AB · 2005
- Descendant · 3 generations on · 26 of its ownK031662 Pressure Wire Sensor, Models 12004/12304Radi Medical Systems AB · 2003
- Descendant · 4 generations on · 25 of its ownK092105 Radianalyzer XpressRadi Medical Systems AB · 2009
Showing 5 of 48 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 48 · See all- K020127Smartflow Pulse Transmission CoefficientFlorence Medical, Ltd. · 2002 · cites it directly47descendants
- K022188Radianalyzer, Model 12710Radi Medical Systems AB · 2002 · 2 generations on46descendants
- K042628Modification to: Radianalyzer, Model 12711Radi Medical Systems AB · 2005 · 3 generations on26descendants
- K031662Pressure Wire Sensor, Models 12004/12304Radi Medical Systems AB · 2003 · 3 generations on26descendants
- K092105Radianalyzer XpressRadi Medical Systems AB · 2009 · 4 generations on25descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K003122 | Smartflow, Model Sfip 2000 | Florence Medical, Ltd. | 2001 | — |
| 0 (this device) | K012947 | Smartflow | Florence Medical, Ltd. | 2001 | — |
| +1 | K020127 | Smartflow Pulse Transmission Coefficient | Florence Medical, Ltd. | 2002 | — |
| +2 | K022188 | Radianalyzer, Model 12710 | Radi Medical Systems AB | 2002 | — |
| +3 | K042628 | Modification to: Radianalyzer, Model 12711 | Radi Medical Systems AB | 2005 | — |
| +3 | K031662 | Pressure Wire Sensor, Models 12004/12304 | Radi Medical Systems AB | 2003 | — |
| +4 | K092105 | Radianalyzer Xpress | Radi Medical Systems AB | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 3 | 0 |
| 2014 | 2 | 0 |
| 2015 | 5 | 0 |
| 2016 | 3 | 0 |
| 2017 | 3 | 0 |
| 2018 | 2 | 0 |
| 2019 | 7 | 0 |
| 2020 | 3 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 4 | 0 |
| 2024 | 1 | 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 |
|---|---|---|---|
| * | K003122 | Smartflow, Model Sfip 2000Summary page 1…roduct Code DQK). Predicate Device: The SmartFlow™ with the Multiple Lesion software is substantially equivalent to the SmartFlow™ (Florence Medical Ltd.) cleared under K003122. Indication for use: Florence Medical Ltd. SmartFlow™ is intended for use in coronary and peripheral vasculature… | 2001 |
What descends from it? (48)
See all 481 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K020127 | Smartflow Pulse Transmission Coefficient | 2002 | 47 |
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?
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?
The SmartFlow™ is intended for use in coronary and peripheral vasculature in conjunction with pressure measurement devices during and after diagnostic procedures, such as angiography, or interventional procedures, such as angioplasty, to evaluate the hemodynamic status of the diseased arteries and to provide further clinical information in the diagnosis and treatment of both coronary and peripheral artery diseases.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K012947 · printed Nov 4, 2026
Cite this page
510(k) Report. “K012947: Smartflow.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K012947
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026