510(k) · Cleared
ClearedACIST RXi System and Navvus II Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Acist Medical Systems, Inc. · OBI Catheter, Pressure Monitoring, Cardiac
Cleared on Sep 13, 2019 as substantially equivalent to K132474 (Acist Medical Systems, 2014) after a 198-day review. Its family tree reaches back 7 generations to 2001. 1 later device descends from it.
- Decided
- Sep 13, 2019
- Review
- 198 days
- Class
- Class II
- Product code
- OBI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K003122 (2001). 14 ancestors in all, the oldest K002067 (2001). 1 later device descends 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 backK132474 Cardiovascular Pressure Measurement (CPM) System, Navvus CatheterAcist Medical Systems · 2014
- This deviceK190473 ACIST RXi System and Navvus II CatheterAcist Medical Systems, Inc. · 2019
- Descendant · cites it directly · 0 of its ownK233904 ACIST RXi System (016616); ACIST Navvus II Catheter (016675_Acist Medical Systems, Inc. · 2024
Most influential descendants
Showing 1 of 1 · See all- K233904ACIST RXi System (016616); ACIST Navvus II Catheter (016675_Acist Medical Systems, Inc. · 2024 · cites it directly0descendants
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 | K132474 | Cardiovascular Pressure Measurement (CPM) System, Navvus Catheter | Acist Medical Systems | 2014 | — |
| 0 (this device) | K190473 | ACIST RXi System and Navvus II Catheter | Acist Medical Systems, Inc. | 2019 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 OBI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K132474 | Cardiovascular Pressure Measurement (CPM) System, Navvus CatheterSummary page 6…Subject Device Predicate Device Comparison of K132474 to Subject Device 510(k) #… | 2014 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K233904 | ACIST RXi System (016616); ACIST Navvus II Catheter (016675_ | 2024 | 0 |
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 18 years and passes through 4 companies; a new generation was cleared every 8 months on median.
- None of the 14 ancestors has a recall.
- Of its descendants, K233904 (Acist Medical Systems, Inc., 2024) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K132474.
How does its category compare?
All OBI devicesOBI Catheter, Pressure Monitoring, Cardiac: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · OBI
1in 2019
2026 to Oct 25, outlined.
Median 510(k) review, days · OBI
Too few OBI 510(k)s in any year since 2007 to give a median.
Recalls per year · OBI
No recall names OBI since 2007.
Adverse event reports per year · OBI
1in 2025
MAUDE reports naming product code OBI, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 2 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 1 | — | 0 | 2 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 11 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 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/K190473 · printed Nov 4, 2026
Cite this page
510(k) Report. “K190473: ACIST RXi System and Navvus II Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K190473
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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