510(k) · Cleared
ClearedPressurewire Certus, Certus (300CM), Aeris, Aeris (300CM), Receiver
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Radi Medical Systems AB · DXO Transducer, Pressure, Catheter Tip
Cleared on Jul 1, 2008 as substantially equivalent to K062769 (Radi Medical Systems AB, 2006) and 3 other predicates after a 102-day review. Its family tree reaches back 6 generations to 2001. 13 later devices descend from it.
- Decided
- Jul 1, 2008
- Review
- 102 days
- Class
- Class II
- Product code
- DXO
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 6 generations to K003122 (2001). 16 ancestors in all, the oldest K883651 (1988). 13 later devices descend from it, 3 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 backK031662 Pressure Wire Sensor, Models 12004/12304Radi Medical Systems AB · 2003
- 1 generation backK062769 Pressurewire Certus, Models 12006 and 12306Radi Medical Systems AB · 2006
- This deviceK080813 Pressurewire Certus, Certus (300CM), Aeris, Aeris (300CM), ReceiverRadi Medical Systems AB · 2008
- Descendant · cites it directly · 8 of its ownK113584 Pressurewire Certus, Certus 300, Aeris, Aeris 300, and ReceiverSt Jude Medical · 2012
- Descendant · 2 generations on · 7 of its ownK131452 Pressurewire; Certus, Certus 300, Aeris, Aeris 300St. Jude Medical Systems AB · 2013
- Descendant · 3 generations on · 2 of its ownK140466 Pressurewire: Aeris Agile Tip, Aeris Agile Tip 300, Certus Agile…St. Jude Medical Systems AB · 2014
- Descendant · cites it directly · 2 of its ownK111201 C7 XR Imaging SystemLightlab Imaging, Inc. · 2011
- Descendant · 4 generations on · 1 of its ownK161171 PressureWire X GuidewireSt. Jude Medical, Inc. · 2016
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K113584Pressurewire Certus, Certus 300, Aeris, Aeris 300, and ReceiverSt Jude Medical · 2012 · cites it directly8descendants
- K131452Pressurewire; Certus, Certus 300, Aeris, Aeris 300St. Jude Medical Systems AB · 2013 · 2 generations on7descendants
- K140466Pressurewire: Aeris Agile Tip, Aeris Agile Tip 300, Certus Agile Tip, Certus Agile Tip 300St. Jude Medical Systems AB · 2014 · 3 generations on2descendants
- K111201C7 XR Imaging SystemLightlab Imaging, Inc. · 2011 · cites it directly2descendants
- K161171PressureWire X GuidewireSt. Jude Medical, Inc. · 2016 · 4 generations on1descendant
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 | K031662 | Pressure Wire Sensor, Models 12004/12304 | Radi Medical Systems AB | 2003 | — |
| −1 | K062769 | Pressurewire Certus, Models 12006 and 12306 | Radi Medical Systems AB | 2006 | — |
| 0 (this device) | K080813 | Pressurewire Certus, Certus (300CM), Aeris, Aeris (300CM), Receiver | Radi Medical Systems AB | 2008 | — |
| +1 | K113584 | Pressurewire Certus, Certus 300, Aeris, Aeris 300, and Receiver | St Jude Medical | 2012 | — |
| +2 | K131452 | Pressurewire; Certus, Certus 300, Aeris, Aeris 300 | St. Jude Medical Systems AB | 2013 | — |
| +3 | K140466 | Pressurewire: Aeris Agile Tip, Aeris Agile Tip 300, Certus Agile Tip, Certus… | St. Jude Medical Systems AB | 2014 | — |
| +1 | K111201 | C7 XR Imaging System | Lightlab Imaging, Inc. | 2011 | — |
| +4 | K161171 | PressureWire X Guidewire | St. Jude Medical, Inc. | 2016 | — |
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 |
|---|---|---|
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 3 | 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? (4)
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 |
|---|---|---|---|
| * | K062769 | Pressurewire Certus, Models 12006 and 12306Summary page 1…equency (870.2910) Diagnostic intravascular catheter. (870.1200) Predicate Devices: PressureWire® (K062769) PressureWire® System (K972793) Wireless Physiologic Monitoring Syste… | 2006 |
| * | K972793 | Pressure Wire Sensor .014, Pressure Wire Interface 10, Pressure Wire Monitor CableSummary page 1…Diagnostic intravascular catheter. (870.1200) Predicate Devices: PressureWire® (K062769) PressureWire® System (K972793) Wireless Physiologic Monitoring System (K053016) Mikro-Tip Catheter… | 1998 |
| * | K053016 | Wireless Physiologic Monitoring SystemSummary page 1…es: PressureWire® (K062769) PressureWire® System (K972793) Wireless Physiologic Monitoring System (K053016) Mikro-Tip Catheter Pressure Transducer (K883 65 1) Description of the Device: PressureWire®V is… | 2005 |
| * | K883651 | Millar Mikro-Tip Catheter Pressure TransducerSummary page 1…re® System (K972793) Wireless Physiologic Monitoring System (K053016) Mikro-Tip Catheter Pressure Transducer (K883 65 1) Description of the Device: PressureWire®V is a .014" guidewire with an integrated pressure and temperature sensor, together wi… | 1988 |
What descends from it? (13)
See all 133 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 7 years and passes through 2 companies; a new generation was cleared every 8 months on median.
- None of the 16 ancestors has a recall.
- Of its descendants, K113584 (St Jude Medical, 2012) has gone furthest, with 8 descendants of its own.
- 1 other device also cites its predicate K062769.
How does its category compare?
All DXO devicesDXO Transducer, Pressure, Catheter Tip: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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® 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 vessel.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080813 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080813: Pressurewire Certus, Certus (300CM), Aeris, Aeris (300CM), Receiver.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080813
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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