510(k) · Cleared
ClearedEagle Eye Gold Ivus Imaging Catheter, Model 85900/859XX; Volcano VH-Ivus System, Model 8049XX-001
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Volcano Corporation · OBJ Catheter, Ultrasound, Intravascular
Cleared on Aug 18, 2005 as substantially equivalent to K031346 (Jomed, Inc., 2003) and 1 other predicate after an 87-day review. Its family tree reaches back 4 generations to 1995. 2 of the 55 devices in its family, counting itself, have a Class I recall. 47 later devices descend from it.
- Decided
- Aug 18, 2005
- Review
- 87 days
- Class
- Class II
- Product code
- OBJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K934139 (1995). 7 ancestors in all. 47 later devices descend from it, 4 citing it directly. 2 of the 55 devices in this family, counting this one, have a Class I recall.
- Root · 4 generations backK934139 Tomtec Echo-ViewTomtec Tomographic Technologies GmbH · 1995
- 3 generations backK993398 Echo View, Easy View, Omni ViewTomtec Imaging Systems GmbH · 1999
- 2 generations backK022824 Echo-View 5.X, Easy-View 2.X, Omni View 2.X, Cardio-View 1.X, LV…Tomtec Imaging Systems GmbH · 2002
- 1 generation backK042188 Volcano Therapeutics, Inc. Volcano Ivus SystemVolcano Therapeutics, Inc. · 2004
- This deviceK051337 Eagle Eye Gold Ivus Imaging Catheter, Model 85900/859XX; Volcano…Volcano Corporation · 2005
- Descendant · cites it directly · 28 of its ownK071554 Volcano S5/S5I Intravascular Imaging and Pressure SystemVolcano Corporation · 2008 · Recalled
- Descendant · 2 generations on · 25 of its ownK082229 S5/S5I Series Intravascular Imaging and Pressure System, Combomap…Volcano Corporation · 2008 · Recalled
- Descendant · 3 generations on · 24 of its ownK111706 Volcano S5IINTRAVASCULAR Imaging and Pressure SystemVolcano Corporation · 2011 · Recalled
- Descendant · 4 generations on · 21 of its ownK123898 Volcano S5/S5I Intravascular Ultrasound Imaging and Pressure SystemVolcano Corporation · 2013 · Recalled
- Descendant · 5 generations on · 18 of its ownK133323 Volcano Ifr ModalityVolcano Corporation · 2014
Showing 5 of 47 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 47 · See all- K071554Volcano S5/S5I Intravascular Imaging and Pressure SystemVolcano Corporation · 2008 · cites it directly28descendants
- K082229S5/S5I Series Intravascular Imaging and Pressure System, Combomap Pressure and Flow SystemVolcano Corporation · 2008 · 2 generations on25descendants
- K111706Volcano S5IINTRAVASCULAR Imaging and Pressure SystemVolcano Corporation · 2011 · 3 generations on24descendants
- K123898Volcano S5/S5I Intravascular Ultrasound Imaging and Pressure SystemVolcano Corporation · 2013 · 4 generations on21descendants
- K133323Volcano Ifr ModalityVolcano Corporation · 2014 · 5 generations on18descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K934139 | Tomtec Echo-View | Tomtec Tomographic Technologies GmbH | 1995 | — |
| −3 | K993398 | Echo View, Easy View, Omni View | Tomtec Imaging Systems GmbH | 1999 | — |
| −2 | K022824 | Echo-View 5.X, Easy-View 2.X, Omni View 2.X, Cardio-View 1.X, LV Analysis 1.X… | Tomtec Imaging Systems GmbH | 2002 | — |
| −1 | K042188 | Volcano Therapeutics, Inc. Volcano Ivus System | Volcano Therapeutics, Inc. | 2004 | — |
| 0 (this device) | K051337 | Eagle Eye Gold Ivus Imaging Catheter, Model 85900/859XX; Volcano VH-Ivus… | Volcano Corporation | 2005 | — |
| +1 | K071554 | Volcano S5/S5I Intravascular Imaging and Pressure System | Volcano Corporation | 2008 | 2 |
| +2 | K082229 | S5/S5I Series Intravascular Imaging and Pressure System, Combomap Pressure and… | Volcano Corporation | 2008 | 3 |
| +3 | K111706 | Volcano S5IINTRAVASCULAR Imaging and Pressure System | Volcano Corporation | 2011 | 1 |
| +4 | K123898 | Volcano S5/S5I Intravascular Ultrasound Imaging and Pressure System | Volcano Corporation | 2013 | 10 |
| +5 | K133323 | Volcano Ifr Modality | Volcano Corporation | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 2 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 4 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 4 | 0 |
| 2014 | 2 | 0 |
| 2015 | 5 | 0 |
| 2016 | 1 | 0 |
| 2017 | 3 | 0 |
| 2018 | 2 | 1 |
| 2019 | 5 | 0 |
| 2020 | 4 | 1 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 3 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 2 | 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.
2 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 OBJ device
- #1 K242893 VERAFEYE System VERAFEYE Imaging Catheter &…score 23.8 · 30 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 |
|---|---|---|---|
| * | K031346 | Jovus Eagle Eye F/X 2.9F Ivus Catheter, Model 85900Summary page 1…: The Eagle Eye Tm Gold IVUS Imaging Catheter is substantially equivalent to: Eagle EyeTM IVUS Imaging Catheter (Intravascular Ultrasound Imaging Catheter) cleared under K031346 on June 23, 2003. The Volcano VH IVUS System is substantially equivalent to: Volcano IVUS System cleared under K042188 on Novemb… | 2003 |
| * | K042188 | Volcano Therapeutics, Inc. Volcano Ivus SystemSummary page 1…scular Ultrasound Imaging Catheter) cleared under K031346 on June 23, 2003. The Volcano VH IVUS System is substantially equivalent to: Volcano IVUS System cleared under K042188 on November 10, 2004. Device Description: The Eagle Eye catheter incorporates a cylindrical ultrasound transducer array. The… | 2004 |
What descends from it? (47)
See all 474 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K071554 | Volcano S5/S5I Intravascular Imaging and Pressure System | 2008 | 28 |
| K073473 | Eagle Eye Gold Ivus Imaging Catheter, Model 85900, Avabar F/X Ivus Imaging Catheter… | 2008 | 14 |
| K091780 | Guided Measurement Catheter (GMC) | 2009 | 1 |
| K072932 | Infraredix Nir Imaging System, Gen. 1.0, Model MC-5 | 2008 | 1 |
Has anything in its family been recalled? (2 Class I)
No FDA recall names this device.
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.
- K172258Novasight Hybrid SystemConavi Medical, Inc. · 2018 · 2 generations on · ◆ in the 2018 descendants bar of FIG. 11 Class I recall
- K193183ACIST HDi System, ACIST Kodama Intravascular Ultrasound CatheterAcist Medical Systems, Inc. · 2020 · 5 generations on · ◆ in the 2020 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 10 years and passes through 4 companies; a new generation was cleared every 2.9 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K071554 (Volcano Corporation, 2008) has gone furthest, with 28 descendants of its own.
How does its category compare?
All OBJ devicesOBJ Catheter, Ultrasound, Intravascular: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · OBJ
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OBJ
35in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OBJ
2in 2020
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · OBJ
791in 2025
MAUDE reports naming product code OBJ, 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 | 3 | 74 | 0 | 0 |
| 2008 | 6 | 100 | 0 | 6 |
| 2009 | 3 | 108 | 0 | 22 |
| 2010 | 1 | — | 0 | 39 |
| 2011 | 4 | 109 | 0 | 47 |
| 2012 | 3 | 136 | 0 | 53 |
| 2013 | 4 | 96 | 0 | 328 |
| 2014 | 3 | 30 | 0 | 609 |
| 2015 | 4 | 131 | 2 | 401 |
| 2016 | 4 | 94 | 0 | 515 |
| 2017 | 6 | 45 | 2 | 524 |
| 2018 | 2 | — | 2 | 542 |
| 2019 | 1 | — | 0 | 237 |
| 2020 | 4 | 135 | 2 | 288 |
| 2021 | 3 | 29 | 0 | 353 |
| 2022 | 3 | 63 | 0 | 473 |
| 2023 | 3 | 63 | 0 | 697 |
| 2024 | 3 | 131 | 0 | 1,154 |
| 2025 | 7 | 35 | 0 | 791 |
| 2026 | 4 | 81 | 1 (1) | — |
What is it indicated for?
The Eagle Eye Gold catheters are designed for use in the evaluation of vascular morphology in blood vessels of the coronary and peripheral vasculature by providing a cross-sectional image of such vessels. This device is not currently indicated for use in cerebral vessels. The Eagle Eye Gold ultrasound imaging catheters are designed for use as an adjunct to conventional angiographic procedures to provide an image of the vessel lumen and wall structures.…
Read the full statement (134 words)
The Eagle Eye Gold catheters are designed for use in the evaluation of vascular morphology in blood vessels of the coronary and peripheral vasculature by providing a cross-sectional image of such vessels. This device is not currently indicated for use in cerebral vessels. The Eagle Eye Gold ultrasound imaging catheters are designed for use as an adjunct to conventional angiographic procedures to provide an image of the vessel lumen and wall structures.
Volcano VH IVUS System is intended to be used in conjunction with imaging catheters during diagnostic ultrasound imaging of the peripheral and coronary vasculature. The Volcano VH IVUS System is intended to semi-automatically visualize boundary features and perform spectral analysis of RF ultrasound signals of vascular featues that the user may wish to examine more closely during routine diagnostic ultrasound imaging examinations.
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/K051337 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051337: Eagle Eye Gold Ivus Imaging Catheter, Model 85900/859XX; Volcano VH-Ivus System, Model 8049XX-001.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051337
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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