510(k) · Cleared
ClearedPressurewire Aeris Agile Tip; Pressurewire Aeris Agile Tip 300
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
St. Jude Medical Systems AB · DRG Transmitters And Receivers, Physiological Signal, Radiofrequency
Cleared on Dec 20, 2013 as substantially equivalent to K131452 (St. Jude Medical Systems AB, 2013) after a 29-day review. Its family tree reaches back 9 generations to 2001.
- Decided
- Dec 20, 2013
- Review
- 29 days
- Class
- Class II
- Product code
- DRG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K003122 (2001). 19 ancestors in all, the oldest K883651 (1988). No later device cites it as a predicate yet.
- Root · 9 generations backK003122 Smartflow, Model Sfip 2000Florence Medical, Ltd. · 2001
- 5 generations between
- 3 generations backK080813 Pressurewire Certus, Certus (300CM), Aeris, Aeris (300CM), ReceiverRadi Medical Systems AB · 2008
- 2 generations backK113584 Pressurewire Certus, Certus 300, Aeris, Aeris 300, and ReceiverSt Jude Medical · 2012
- 1 generation backK131452 Pressurewire; Certus, Certus 300, Aeris, Aeris 300St. Jude Medical Systems AB · 2013
- This deviceK133587 Pressurewire Aeris Agile Tip; Pressurewire Aeris Agile Tip 300St. Jude Medical Systems AB · 2013
Show all 9 generations
- Root · 9 generations backK003122 Smartflow, Model Sfip 2000Florence Medical, Ltd. · 2001
- 8 generations backK012947 SmartflowFlorence Medical, Ltd. · 2001
- 7 generations backK020127 Smartflow Pulse Transmission CoefficientFlorence Medical, Ltd. · 2002
- 6 generations backK022188 Radianalyzer, Model 12710Radi Medical Systems AB · 2002
- 5 generations backK031662 Pressure Wire Sensor, Models 12004/12304Radi Medical Systems AB · 2003
- 4 generations backK062769 Pressurewire Certus, Models 12006 and 12306Radi Medical Systems AB · 2006
- 3 generations backK080813 Pressurewire Certus, Certus (300CM), Aeris, Aeris (300CM), ReceiverRadi Medical Systems AB · 2008
- 2 generations backK113584 Pressurewire Certus, Certus 300, Aeris, Aeris 300, and ReceiverSt Jude Medical · 2012
- 1 generation backK131452 Pressurewire; Certus, Certus 300, Aeris, Aeris 300St. Jude Medical Systems AB · 2013
- This deviceK133587 Pressurewire Aeris Agile Tip; Pressurewire Aeris Agile Tip 300St. Jude Medical Systems AB · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K003122 | Smartflow, Model Sfip 2000 | Florence Medical, Ltd. | 2001 | — |
| −8 | K012947 | Smartflow | Florence Medical, Ltd. | 2001 | — |
| −7 | K020127 | Smartflow Pulse Transmission Coefficient | Florence Medical, Ltd. | 2002 | — |
| −6 | K022188 | Radianalyzer, Model 12710 | Radi Medical Systems AB | 2002 | — |
| −5 | K031662 | Pressure Wire Sensor, Models 12004/12304 | Radi Medical Systems AB | 2003 | — |
| −4 | K062769 | Pressurewire Certus, Models 12006 and 12306 | Radi Medical Systems AB | 2006 | — |
| −3 | K080813 | Pressurewire Certus, Certus (300CM), Aeris, Aeris (300CM), Receiver | Radi Medical Systems AB | 2008 | — |
| −2 | 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 | — |
| 0 (this device) | K133587 | Pressurewire Aeris Agile Tip; Pressurewire Aeris Agile Tip 300 | St. Jude Medical Systems AB | 2013 | — |
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 |
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 DRG? 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 DRG device
- #1 K223711 ANNE Onescore 20.8 · 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 |
|---|---|---|---|
| * | K131452 | Pressurewire; Certus, Certus 300, Aeris, Aeris 300Summary page 1…Transmitters and Receivers, physiological signal, radiofrequency (870.2910) (K 13 1452) PressureWirem AeriSTM cleared September 5, 2013 Predicate Device:… | 2013 |
What descends from it?
No later submission names this one as a predicate yet.
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 12 years and passes through 4 companies; a new generation was cleared every 8 months on median.
- None of the 19 ancestors has a recall.
- 3 other devices also cite its predicate K131452.
How does its category compare?
All DRG devicesDRG Transmitters And Receivers, Physiological Signal, Radiofrequency: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · DRG
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DRG
127in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DRG
3in 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DRG
52in 2025
MAUDE reports naming product code DRG, 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 | 6 | 63 | 3 | 14 |
| 2008 | 5 | 74 | 0 | 9 |
| 2009 | 13 | 94 | 0 | 5 |
| 2010 | 10 | 68 | 0 | 13 |
| 2011 | 9 | 104 | 0 | 12 |
| 2012 | 12 | 103 | 0 | 9 |
| 2013 | 13 | 146 | 0 | 13 |
| 2014 | 10 | 177 | 0 | 97 |
| 2015 | 2 | — | 0 | 131 |
| 2016 | 2 | — | 0 | 182 |
| 2017 | 7 | 98 | 0 | 484 |
| 2018 | 6 | 220 | 0 | 166 |
| 2019 | 5 | 122 | 0 | 70 |
| 2020 | 6 | 159 | 0 | 82 |
| 2021 | 2 | — | 0 | 107 |
| 2022 | 6 | 287 | 0 | 43 |
| 2023 | 4 | 212 | 0 | 19 |
| 2024 | 3 | 125 | 0 | 26 |
| 2025 | 3 | 127 | 0 | 52 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
PressureWireM 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/K133587 · printed Nov 4, 2026
Cite this page
510(k) Report. “K133587: Pressurewire Aeris Agile Tip; Pressurewire Aeris Agile Tip 300.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K133587
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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