510(k) · Cleared
ClearedCardiovascular Pressure Measurement (CPM) System, Navvus Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Acist Medical Systems · DXO Transducer, Pressure, Catheter Tip
Cleared on Jan 30, 2014 as substantially equivalent to K062769 (Radi Medical Systems AB, 2006) after a 176-day review. Its family tree reaches back 6 generations to 2001. 10 later devices descend from it.
- Decided
- Jan 30, 2014
- Review
- 176 days
- Class
- Class II
- Product code
- DXO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K003122 (2001). 13 ancestors in all, the oldest K002067 (2001). 10 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 deviceK132474 Cardiovascular Pressure Measurement (CPM) System, Navvus CatheterAcist Medical Systems · 2014
- Descendant · cites it directly · 4 of its ownK141275 Endophys Pressure Sensing Sheath KitEndophys, Inc. · 2015
- Descendant · 2 generations on · 3 of its ownK160272 Endophys Pressure Sensing Sheath KitEndophys, Inc. · 2016
- Descendant · cites it directly · 2 of its ownK141615 Endophys Blood Pressure MonitorEndophys, Inc. · 2015
- Descendant · cites it directly · 1 of its ownK190473 ACIST RXi System and Navvus II CatheterAcist Medical Systems, Inc. · 2019
- Descendant · 3 generations on · 1 of its ownK173399 Endophys Pressure Sensing Sheath Kit- 8FEndophys Holdings, LLC · 2017
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K141275Endophys Pressure Sensing Sheath KitEndophys, Inc. · 2015 · cites it directly4descendants
- K160272Endophys Pressure Sensing Sheath KitEndophys, Inc. · 2016 · 2 generations on3descendants
- K141615Endophys Blood Pressure MonitorEndophys, Inc. · 2015 · cites it directly2descendants
- K190473ACIST RXi System and Navvus II CatheterAcist Medical Systems, Inc. · 2019 · cites it directly1descendant
- K173399Endophys Pressure Sensing Sheath Kit- 8FEndophys Holdings, LLC · 2017 · 3 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) | K132474 | Cardiovascular Pressure Measurement (CPM) System, Navvus Catheter | Acist Medical Systems | 2014 | — |
| +1 | K141275 | Endophys Pressure Sensing Sheath Kit | Endophys, Inc. | 2015 | — |
| +2 | K160272 | Endophys Pressure Sensing Sheath Kit | Endophys, Inc. | 2016 | — |
| +1 | K141615 | Endophys Blood Pressure Monitor | Endophys, Inc. | 2015 | — |
| +1 | K190473 | ACIST RXi System and Navvus II Catheter | Acist Medical Systems, Inc. | 2019 | — |
| +3 | K173399 | Endophys Pressure Sensing Sheath Kit- 8F | Endophys Holdings, LLC | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 3 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 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 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 |
|---|---|---|---|
| * | K062769 | Pressurewire Certus, Models 12006 and 12306Summary page 5…ire® ACIST Rapid Exchange (RXi) System and Characteristic (RADI Medical Systems, St. Jude avsCter Medical, Minnesota, USA) (K062769)NavsCter PressureWire is designed to fit inside a percutaneous catheter for the purpose of… | 2006 |
What descends from it? (10)
3 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 13 years and passes through 3 companies; a new generation was cleared every 8 months on median.
- None of the 13 ancestors has a recall.
- Of its descendants, K141275 (Endophys, Inc., 2015) has gone furthest, with 4 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. 2014, 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?
The ACIST Rapid Exchange (RXI) System is indicated for obtaining intravascular pressure measurements for use in the diagnosis and treatment of coronary and peripheral artery disease. The Navvus Catheter is intended for use with the ACIST RXi System.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132474 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132474: Cardiovascular Pressure Measurement (CPM) System, Navvus Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132474
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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