510(k) · Cleared
ClearedForesight Intracardiac Echocardiology (ICE) System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Conavi Medical, Inc. · DQO Catheter, Intravascular, Diagnostic
Cleared on Mar 28, 2017 as substantially equivalent to K151126 (Colibri Technologies, Inc., 2015) and 1 other predicate after a 175-day review. Its family tree reaches back 3 generations to 1992.
- Decided
- Mar 28, 2017
- Review
- 175 days
- Class
- Class II
- Product code
- DQO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K921750 (1992). 8 ancestors in all, the oldest K921148 (1992). No later device cites it as a predicate yet.
- Root · 3 generations backK921750 Cvis Insight Iii SystemCardiovascular Imaging Systems, Inc. · 1992
- 2 generations backK980851 Galaxy Intravascular Ultrasound System, Model I5028Boston Scientific Corp · 1998
- 1 generation backK151126 Foresight Intracardiac Echocardiography (ICE) SystemColibri Technologies, Inc. · 2015
- This deviceK162789 Foresight Intracardiac Echocardiology (ICE) SystemConavi Medical, Inc. · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K921750 | Cvis Insight Iii System | Cardiovascular Imaging Systems, Inc. | 1992 | — |
| −2 | K980851 | Galaxy Intravascular Ultrasound System, Model I5028 | Boston Scientific Corp | 1998 | — |
| −1 | K151126 | Foresight Intracardiac Echocardiography (ICE) System | Colibri Technologies, Inc. | 2015 | — |
| 0 (this device) | K162789 | Foresight Intracardiac Echocardiology (ICE) System | Conavi Medical, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1997 | 1 | 0 |
| 1999 | 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? (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 |
|---|---|---|---|
| * | K151126 | Foresight Intracardiac Echocardiography (ICE) SystemSummary page 4…lass II Panel: Division of Cardiovascular Devices Predicate Device: Conavi Medical (Formerly Colibri Technologies) ICE system K151126 Acuson Corp. AcuNavTM Diagnostic Ultrasound Catheter K992631 Device Description The Foresight ICE S… | 2015 |
| * | K992631 | Acunav Diagnostic Ultrasound CatheterSummary page 4… Conavi Medical (Formerly Colibri Technologies) ICE system K151126 Acuson Corp. AcuNavTM Diagnostic Ultrasound Catheter K992631 Device Description The Foresight ICE System is intended to be used for real-time, minimally-invasive guidance of several differe… | 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 25 years and passes through 4 companies; a new generation was cleared every 5.8 years on median.
- 1 of the 8 ancestors has a recall of any class.
How does its category compare?
All DQO devicesDQO Catheter, Intravascular, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 Foresight Intracardiac Echocardiography (ICE) System is indicated for intracardiac and intraluminal ultrasound visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart and great vessels of patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162789 · printed Nov 5, 2026
Cite this page
510(k) Report. “K162789: Foresight Intracardiac Echocardiology (ICE) System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K162789
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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