510(k) · Cleared
ClearedPressurewire Certus, Certus 300, Aeris, Aeris 300, and Receiver
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
St Jude Medical · DXO Transducer, Pressure, Catheter Tip
Cleared on Mar 2, 2012 as substantially equivalent to K080813 (Radi Medical Systems AB, 2008) after an 88-day review. Its family tree reaches back 7 generations to 2001. 8 later devices descend from it.
- Decided
- Mar 2, 2012
- Review
- 88 days
- Class
- Class II
- Product code
- DXO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K003122 (2001). 17 ancestors in all, the oldest K883651 (1988). 8 later devices descend from it, 1 citing it directly.
- Root · 7 generations backK003122 Smartflow, Model Sfip 2000Florence Medical, Ltd. · 2001
- 6 generations backK012947 SmartflowFlorence Medical, Ltd. · 2001
- 5 generations backK020127 Smartflow Pulse Transmission CoefficientFlorence Medical, Ltd. · 2002
- 4 generations backK022188 Radianalyzer, Model 12710Radi Medical Systems AB · 2002
- 3 generations backK031662 Pressure Wire Sensor, Models 12004/12304Radi Medical Systems AB · 2003
- 2 generations backK062769 Pressurewire Certus, Models 12006 and 12306Radi Medical Systems AB · 2006
- 1 generation backK080813 Pressurewire Certus, Certus (300CM), Aeris, Aeris (300CM), ReceiverRadi Medical Systems AB · 2008
- This deviceK113584 Pressurewire Certus, Certus 300, Aeris, Aeris 300, and ReceiverSt Jude Medical · 2012
- Descendant · cites it directly · 7 of its ownK131452 Pressurewire; Certus, Certus 300, Aeris, Aeris 300St. Jude Medical Systems AB · 2013
- Descendant · 2 generations on · 2 of its ownK140466 Pressurewire: Aeris Agile Tip, Aeris Agile Tip 300, Certus Agile…St. Jude Medical Systems AB · 2014
- Descendant · 3 generations on · 1 of its ownK161171 PressureWire X GuidewireSt. Jude Medical, Inc. · 2016
- Descendant · 2 generations on · 1 of its ownK151610 Comet Pressure GuidewireBoston Scientific Corporation · 2015
- Descendant · 3 generations on · 0 of its ownK193279 Comet II Pressure GuidewireBoston Scientific Corporation · 2019
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K131452Pressurewire; Certus, Certus 300, Aeris, Aeris 300St. Jude Medical Systems AB · 2013 · cites it directly7descendants
- K140466Pressurewire: Aeris Agile Tip, Aeris Agile Tip 300, Certus Agile Tip, Certus Agile Tip 300St. Jude Medical Systems AB · 2014 · 2 generations on2descendants
- K161171PressureWire X GuidewireSt. Jude Medical, Inc. · 2016 · 3 generations on1descendant
- K151610Comet Pressure GuidewireBoston Scientific Corporation · 2015 · 2 generations on1descendant
- K193279Comet II Pressure GuidewireBoston Scientific Corporation · 2019 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K003122 | Smartflow, Model Sfip 2000 | Florence Medical, Ltd. | 2001 | — |
| −6 | K012947 | Smartflow | Florence Medical, Ltd. | 2001 | — |
| −5 | K020127 | Smartflow Pulse Transmission Coefficient | Florence Medical, Ltd. | 2002 | — |
| −4 | K022188 | Radianalyzer, Model 12710 | Radi Medical Systems AB | 2002 | — |
| −3 | K031662 | Pressure Wire Sensor, Models 12004/12304 | Radi Medical Systems AB | 2003 | — |
| −2 | K062769 | Pressurewire Certus, Models 12006 and 12306 | Radi Medical Systems AB | 2006 | — |
| −1 | K080813 | Pressurewire Certus, Certus (300CM), Aeris, Aeris (300CM), Receiver | Radi Medical Systems AB | 2008 | — |
| 0 (this device) | K113584 | Pressurewire Certus, Certus 300, Aeris, Aeris 300, and Receiver | St Jude Medical | 2012 | — |
| +1 | K131452 | Pressurewire; Certus, Certus 300, Aeris, Aeris 300 | St. Jude Medical Systems AB | 2013 | — |
| +2 | K140466 | Pressurewire: Aeris Agile Tip, Aeris Agile Tip 300, Certus Agile Tip, Certus… | St. Jude Medical Systems AB | 2014 | — |
| +3 | K161171 | PressureWire X Guidewire | St. Jude Medical, Inc. | 2016 | — |
| +2 | K151610 | Comet Pressure Guidewire | Boston Scientific Corporation | 2015 | — |
| +3 | K193279 | Comet II Pressure Guidewire | Boston Scientific Corporation | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1998 | 1 | 0 |
| 2001 | 3 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 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 DXO? 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 DXO device
- #1 K241418 OptoMonitor 3score 14.8 · 11 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 |
|---|---|---|---|
| * | K080813 | Pressurewire Certus, Certus (300CM), Aeris, Aeris (300CM), ReceiverSummary page 1…s and Receivers, physiological signal, radiofrequency (870.29 10) Product Code DXO, DQX and DRG Predicate Device: K0808 13 PressureWire® Aeris & Receiver. Establishment Registration: 8030904 Establishment: St. Jude Medical Systems AB… | 2008 |
What descends from it? (8)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K131452 | Pressurewire; Certus, Certus 300, Aeris, Aeris 300 | 2013 | 7 |
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 11 years and passes through 3 companies; a new generation was cleared every 8 months on median.
- None of the 17 ancestors has a recall.
- Of its descendants, K131452 (St. Jude Medical Systems AB, 2013) has gone furthest, with 7 descendants of its own.
- 2 other devices also cite its predicate K080813.
How does its category compare?
All DXO devicesDXO Transducer, Pressure, Catheter Tip: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · DXO
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DXO
120in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DXO
1in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DXO
183in 2025
MAUDE reports naming product code DXO, 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 | 1 | — | 0 | 3 |
| 2008 | 1 | — | 0 | 2 |
| 2009 | 0 | — | 0 | 8 |
| 2010 | 1 | — | 0 | 74 |
| 2011 | 1 | — | 0 | 111 |
| 2012 | 1 | — | 0 | 82 |
| 2013 | 1 | — | 0 | 93 |
| 2014 | 3 | 176 | 0 | 85 |
| 2015 | 2 | — | 1 | 114 |
| 2016 | 2 | — | 0 | 152 |
| 2017 | 2 | — | 0 | 186 |
| 2018 | 1 | — | 0 | 179 |
| 2019 | 4 | 120 | 0 | 153 |
| 2020 | 2 | — | 0 | 158 |
| 2021 | 0 | — | 0 | 116 |
| 2022 | 1 | — | 0 | 144 |
| 2023 | 0 | — | 0 | 194 |
| 2024 | 1 | — | 0 | 197 |
| 2025 | 1 | — | 0 | 183 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
PressureWire TM is indicated to direct a catheter through a blood vessel and to measure physiological parameters in the heart and in the coronary and peripheral blood vessels.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113584 · printed Nov 5, 2026
Cite this page
510(k) Report. “K113584: Pressurewire Certus, Certus 300, Aeris, Aeris 300, and Receiver.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K113584
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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