510(k) · Cleared
ClearedIbi Inquiry Clearice Intracardiac Echocardiography Ultrasound Imaging Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Irvine Biomedical,Inc.(Ibi) · DQO Catheter, Intravascular, Diagnostic
Cleared on Mar 20, 2007 as substantially equivalent to K042593 (Siemens Medical Solutions USA, Inc., 2004) and 2 other predicates after a 76-day review. Its family tree reaches back 4 generations to 1992.
- Decided
- Mar 20, 2007
- Review
- 76 days
- Class
- Class II
- Product code
- DQO
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K921148 (1992). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK921148 Cvis Insight Catheters for Intracardiac UseCardiovascular Imaging Systems, Inc. · 1992
- 3 generations backK992631 Acunav Diagnostic Ultrasound CatheterAcuson Corp. · 1999 · Recalled
- 2 generations backK033650 Acunav 90/10 Diagnostic Ultrasound CatheterSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 1 generation backK042593 Acuson Acunav 8F Ultrasound CatheterSiemens Medical Solutions USA, Inc. · 2004
- This deviceK070011 Ibi Inquiry Clearice Intracardiac Echocardiography Ultrasound…Irvine Biomedical,Inc.(Ibi) · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K921148 | Cvis Insight Catheters for Intracardiac Use | Cardiovascular Imaging Systems, Inc. | 1992 | — |
| −3 | K992631 | Acunav Diagnostic Ultrasound Catheter | Acuson Corp. | 1999 | 1 |
| −2 | K033650 | Acunav 90/10 Diagnostic Ultrasound Catheter | Siemens Medical Solutions USA, Inc. | 2004 | 1 |
| −1 | K042593 | Acuson Acunav 8F Ultrasound Catheter | Siemens Medical Solutions USA, Inc. | 2004 | — |
| 0 (this device) | K070011 | Ibi Inquiry Clearice Intracardiac Echocardiography Ultrasound Imaging Catheter | Irvine Biomedical,Inc.(Ibi) | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2001 | 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 DQO? 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? (3)
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 |
|---|---|---|---|
| * | K042593 | Acuson Acunav 8F Ultrasound CatheterSummary page 1…Ultrasound Transducer 892.1570 90-ITX Diagnostic Ultrasound Catheter 870.1200 74-DQO Predicate Devices: • #K042593 (January 5, 2005) cleared as ACUSON AcuNav 8Fr Ultrasound Catheter. · #K033650 (February 24, 2004) cleared as ACUSON Ac… | 2004 |
| * | K033650 | Acunav 90/10 Diagnostic Ultrasound CatheterSummary page 1…Catheter 870.1200 74-DQO Predicate Devices: • #K042593 (January 5, 2005) cleared as ACUSON AcuNav 8Fr Ultrasound Catheter. · #K033650 (February 24, 2004) cleared as ACUSON AcuNav 90/10 Diagnostic Ultrasound Catheter. * #K992632 (November 8, 2001) cleare… | 2004 |
| * | K992631 | Acunav Diagnostic Ultrasound Catheter Our reading of the summary gave K992632, FDA’s number for Immulite Amphetamine, Models LKAM1, LKAM5 (Diagnostic Products Corp.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “ACUSON AcuNav Diagnostic Ultrasound Catheter”. | 1999 |
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 15 years and passes through 4 companies; a new generation was cleared every 4.2 years on median.
- 2 of the 6 ancestors have a recall of any class.
- 2 other devices also cite its predicate K042593.
How does its category compare?
All DQO devicesDQO Catheter, Intravascular, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
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?
The IBI InquiryTM ClearICETM Intracardiac Echocardiography Catheter is intended for
intra-cardiac and intra-luminal visualization of cardiac anatomy and physiology as well
as visualization of other devices in the heart.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070011 · printed Nov 5, 2026
Cite this page
510(k) Report. “K070011: Ibi Inquiry Clearice Intracardiac Echocardiography Ultrasound Imaging Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K070011
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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