510(k) · Cleared
ClearedACIST RXi System (016616); ACIST Navvus II Catheter (016675_
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Acist Medical Systems, Inc. · DXO Transducer, Pressure, Catheter Tip
Cleared on Jul 17, 2024 as substantially equivalent to K190473 (Acist Medical Systems, Inc., 2019) after a 219-day review. Its family tree reaches back 8 generations to 2001.
- Decided
- Jul 17, 2024
- Review
- 219 days
- Class
- Class II
- Product code
- DXO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K003122 (2001). 15 ancestors in all, the oldest K002067 (2001). No later device cites it as a predicate yet.
- Root · 8 generations backK003122 Smartflow, Model Sfip 2000Florence Medical, Ltd. · 2001
- 7 generations backK012947 SmartflowFlorence Medical, Ltd. · 2001
- 6 generations backK020127 Smartflow Pulse Transmission CoefficientFlorence Medical, Ltd. · 2002
- 5 generations backK022188 Radianalyzer, Model 12710Radi Medical Systems AB · 2002
- 4 generations backK031662 Pressure Wire Sensor, Models 12004/12304Radi Medical Systems AB · 2003
- 3 generations backK062769 Pressurewire Certus, Models 12006 and 12306Radi Medical Systems AB · 2006
- 2 generations backK132474 Cardiovascular Pressure Measurement (CPM) System, Navvus CatheterAcist Medical Systems · 2014
- 1 generation backK190473 ACIST RXi System and Navvus II CatheterAcist Medical Systems, Inc. · 2019
- This deviceK233904 ACIST RXi System (016616); ACIST Navvus II Catheter (016675_Acist Medical Systems, Inc. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K003122 | Smartflow, Model Sfip 2000 | Florence Medical, Ltd. | 2001 | — |
| −7 | K012947 | Smartflow | Florence Medical, Ltd. | 2001 | — |
| −6 | K020127 | Smartflow Pulse Transmission Coefficient | Florence Medical, Ltd. | 2002 | — |
| −5 | K022188 | Radianalyzer, Model 12710 | Radi Medical Systems AB | 2002 | — |
| −4 | K031662 | Pressure Wire Sensor, Models 12004/12304 | Radi Medical Systems AB | 2003 | — |
| −3 | K062769 | Pressurewire Certus, Models 12006 and 12306 | Radi Medical Systems AB | 2006 | — |
| −2 | K132474 | Cardiovascular Pressure Measurement (CPM) System, Navvus Catheter | Acist Medical Systems | 2014 | — |
| −1 | K190473 | ACIST RXi System and Navvus II Catheter | Acist Medical Systems, Inc. | 2019 | — |
| 0 (this device) | K233904 | ACIST RXi System (016616); ACIST Navvus II Catheter (016675_ | Acist Medical Systems, Inc. | 2024 | — |
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 |
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 |
|---|---|---|---|
| * | K190473 | ACIST RXi System and Navvus II CatheterSummary page 5…assification Name: Transducer, pressure, catheter tip (870.2870) Regulatory Class: II Product Code: DXO PREDICATE DEVICE ACIST RXi® System and Navvus®II MicroCatheter (K190473) REFERENCE DEVICE The dPR index calculation algorithm software upgrade subject to this submission is substantially equivalent to… | 2019 |
| † | K173860 | s5 Intravascular Ultrasound Imaging and Pressure Systems, s5i Intravascular Ultrasound… | 2018 |
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 23 years and passes through 4 companies; a new generation was cleared every 3.5 years on median.
- None of the 15 ancestors has a recall.
How does its category compare?
All DXO devicesDXO Transducer, Pressure, Catheter Tip: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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 RXi System is indicated for obtaining intravascular pressure measurements for use in the diagnosis and treatment of coronary and peripheral artery disease. The ACIST Navvus II MicroCatheter is intended for use with the ACIST RXi System.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K233904 · printed Nov 6, 2026
Cite this page
510(k) Report. “K233904: ACIST RXi System (016616); ACIST Navvus II Catheter (016675_.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K233904
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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