510(k) · Cleared
Recalled · 2009Acunav Diagnostic Ultrasound Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Acuson Corp. · DQO Catheter, Intravascular, Diagnostic
Cleared on Dec 15, 1999 as substantially equivalent to K970049 (Cardiovascular Imaging Systems, Inc., 1997) and 1 other predicate after a 131-day review. Its family tree reaches back 1 generation to 1992. 3 of the 1,096 devices in its family, counting itself, have a Class I recall. 1,093 later devices descend from it. It has been recalled once.
- Decided
- Dec 15, 1999
- Review
- 131 days
- Class
- Class II
- Product code
- DQO
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 1 generation to K921148 (1992). 2 ancestors in all. 1,093 later devices descend from it, 9 citing it directly. 3 of the 1,096 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK921148 Cvis Insight Catheters for Intracardiac UseCardiovascular Imaging Systems, Inc. · 1992
- This deviceK992631 Acunav Diagnostic Ultrasound CatheterAcuson Corp. · 1999
- Descendant · cites it directly · 1,069 of its ownK022567 Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
- Descendant · 2 generations on · 1,003 of its ownK032114 Sequoia 8.0 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2003
- Descendant · 3 generations on · 988 of its ownK041319 Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004
- Descendant · 4 generations on · 979 of its ownK051139 Acuson Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005
- Descendant · 5 generations on · 972 of its ownK052410 Acuson Sequoia Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005
Showing 5 of 1,093 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 1,093 · See all- K022567Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002 · cites it directly1,069descendants
- K032114Sequoia 8.0 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2003 · 2 generations on1,003descendants
- K041319Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004 · 3 generations on988descendants
- K051139Acuson Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005 · 4 generations on979descendants
- K052410Acuson Sequoia Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005 · 5 generations on972descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K921148 | Cvis Insight Catheters for Intracardiac Use | Cardiovascular Imaging Systems, Inc. | 1992 | — |
| 0 (this device) | K992631 | Acunav Diagnostic Ultrasound Catheter | Acuson Corp. | 1999 | — |
| +1 | K022567 | Sequoia Signature II Diagnostic Ultrasound System | Acuson Corp. | 2002 | — |
| +2 | K032114 | Sequoia 8.0 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2003 | — |
| +3 | K041319 | Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2004 | — |
| +4 | K051139 | Acuson Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2005 | — |
| +5 | K052410 | Acuson Sequoia Ultrasound System | Siemens Medical Solutions USA, Inc. | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 3 | 0 |
| 2004 | 12 | 0 |
| 2005 | 15 | 0 |
| 2006 | 12 | 0 |
| 2007 | 21 | 0 |
| 2008 | 19 | 0 |
| 2009 | 25 | 0 |
| 2010 | 24 | 0 |
| 2011 | 36 | 0 |
| 2012 | 40 | 0 |
| 2013 | 45 | 0 |
| 2014 | 54 | 0 |
| 2015 | 60 | 0 |
| 2016 | 64 | 0 |
| 2017 | 80 | 0 |
| 2018 | 69 | 0 |
| 2019 | 50 | 0 |
| 2020 | 77 | 0 |
| 2021 | 56 | 0 |
| 2022 | 61 | 0 |
| 2023 | 60 | 0 |
| 2024 | 68 | 0 |
| 2025 | 85 | 3 |
| 2026 | 56 | 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.
3 devices in this family have a Class I recall. 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 DQO device
- #1 K254278 Arterial Pressure Monitoring Set/Trayscore 14.4 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K970049 | BSC, Sonicath Ultra Imaging Catheter 3.2F/20MHZ (37410/456221 & BSC, Sonicath Ultra…Summary page 2…ers--class II (21 C.F.R. §§ 870.1200 and 892.1570) Predicate Devices: 1. Boston Scientific Corporation’s Sonicath Ultra™ Imaging Catheter (9 Fr/ 9 MHz) (K970049), (used in conjunction with EP Technologies’ Galaxy Intravascular Ultrasound Imaging System (K980851)) 2. Cardiovascular Imaging… | 1997 |
| * | K921148 | Cvis Insight Catheters for Intracardiac UseSummary page 2…with EP Technologies’ Galaxy Intravascular Ultrasound Imaging System (K980851)) 2. Cardiovascular Imaging Systems’ (CVIS) Insight Catheter for Intracardiac Use (10 Fr) (K921148). Device Description: The AcuNav is an ultrasound-tipped catheter device which is used directly within the vasculature and/or t… | 1992 |
What descends from it? (1,093)
See all 1,0939 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K022567 | Sequoia Signature II Diagnostic Ultrasound System | 2002 | 1,069 |
| K033650 | Acunav 90/10 Diagnostic Ultrasound Catheter | 2004 | 945 |
| K042593 | Acuson Acunav 8F Ultrasound Catheter | 2004 | 930 |
| K162789 | Foresight Intracardiac Echocardiology (ICE) System | 2017 | 0 |
| K070051 | Acumen Insight Endocardial Visualization System | 2007 | 0 |
| K063076 | Reprocessed Diagnostic Ultrasound Catheter | 2007 | 0 |
| K070011 | Ibi Inquiry Clearice Intracardiac Echocardiography Ultrasound Imaging Catheter | 2007 | 0 |
| K033436 | Reprocessed Diagnostic Ultrasound Catheter | 2005 | 0 |
| K043453 | Sterilemed Reprocessed Ivus Imaging Catheter | 2005 | 0 |
Has anything in its family been recalled? (3 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 20, 2009 | Not classified | Z-1745-2011 | Process design | Screen Image Quality. An assembly issue on SwiftLink connectors may cause reduced/degraded image quality when using ACUSON AcuNav ultrasound catheter transducers. |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K250545Medline ReNewal Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter (8F, 8FG, 10F, 10FG)Surgical Instrument Service and Savings, Inc. · 2025 · 4 generations on · ◆ in the 2025 descendants bar of FIG. 11 Class I recall
- K242670Lumify Diagnostic Ultrasound SystemPhilips Ultrasound · 2025 · 12 generations on · ◆ in the 2025 descendants bar of FIG. 11 Class I recall
- K242519Lumify Diagnostic Ultrasound SystemPhilips Ultrasound · 2025 · 12 generations on · ◆ in the 2025 descendants bar of FIG. 11 Class I recall
What does this lineage say?
How does its category compare?
All DQO devicesDQO Catheter, Intravascular, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DQO
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DQO
148in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQO
1in 2023
Class I (11 since 2007) Class II/III not classified
Adverse event reports per year · DQO
656in 2025
MAUDE reports naming product code DQO, 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 | 8 | 106 | 14 | 564 |
| 2008 | 3 | 80 | 4 | 726 |
| 2009 | 8 | 58 | 7 | 933 |
| 2010 | 7 | 137 | 11 | 556 |
| 2011 | 6 | 74 | 7 | 625 |
| 2012 | 15 | 94 | 2 | 532 |
| 2013 | 2 | — | 1 | 753 |
| 2014 | 3 | 109 | 0 | 601 |
| 2015 | 10 | 209 | 1 (1) | 628 |
| 2016 | 4 | 89 | 2 (1) | 614 |
| 2017 | 10 | 176 | 1 | 873 |
| 2018 | 10 | 234 | 2 | 777 |
| 2019 | 6 | 113 | 71 | 386 |
| 2020 | 3 | 30 | 4 (4) | 312 |
| 2021 | 1 | — | 0 | 338 |
| 2022 | 4 | 181 | 1 | 379 |
| 2023 | 4 | 73 | 1 (1) | 391 |
| 2024 | 4 | 148 | 0 | 511 |
| 2025 | 2 | — | 0 | 656 |
| 2026 | 3 | 85 | 24 (4) | — |
What is it indicated for?
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
The AcuNav™ Diagnostic Ultrasound Catheter is intended for intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart. The AcuNav™ is intended for use in right heart only.
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
The AcuNav™ Diagnostic Ultrasound Catheter is intended for intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart. The AcuNav™ is intended for use in right heart only.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K992631 · printed Nov 4, 2026
Cite this page
510(k) Report. “K992631: Acunav Diagnostic Ultrasound Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K992631
Report an extraction error
Are you the manufacturer?
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