510(k) · Cleared
ClearedJovus Eagle Eye F/X 2.9F Ivus Catheter, Model 85900
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Jomed, Inc. · OBJ Catheter, Ultrasound, Intravascular
Cleared on Jun 23, 2003 as substantially equivalent to K000820 (Endosonics Corp., 2000) after a 55-day review. Its family tree reaches back 1 generation to 2000. 2 of the 50 devices in its family, counting itself, have a Class I recall. 48 later devices descend from it.
- Decided
- Jun 23, 2003
- Review
- 55 days
- Class
- Class II
- Product code
- OBJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K000820 (2000). 48 later devices descend from it, 1 citing it directly. 2 of the 50 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK000820 Avanar F/X 2.9F Intravascular Ultrasound Imaging Catheter, Model 85700Endosonics Corp. · 2000
- This deviceK031346 Jovus Eagle Eye F/X 2.9F Ivus Catheter, Model 85900Jomed, Inc. · 2003
- Descendant · cites it directly · 47 of its ownK051337 Eagle Eye Gold Ivus Imaging Catheter, Model 85900/859XX; Volcano…Volcano Corporation · 2005
- Descendant · 2 generations on · 28 of its ownK071554 Volcano S5/S5I Intravascular Imaging and Pressure SystemVolcano Corporation · 2008 · Recalled
- Descendant · 3 generations on · 25 of its ownK082229 S5/S5I Series Intravascular Imaging and Pressure System, Combomap…Volcano Corporation · 2008 · Recalled
- Descendant · 4 generations on · 24 of its ownK111706 Volcano S5IINTRAVASCULAR Imaging and Pressure SystemVolcano Corporation · 2011 · Recalled
- Descendant · 5 generations on · 21 of its ownK123898 Volcano S5/S5I Intravascular Ultrasound Imaging and Pressure SystemVolcano Corporation · 2013 · Recalled
Showing 5 of 48 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 48 · See all- K051337Eagle Eye Gold Ivus Imaging Catheter, Model 85900/859XX; Volcano VH-Ivus System, Model…Volcano Corporation · 2005 · cites it directly47descendants
- K071554Volcano S5/S5I Intravascular Imaging and Pressure SystemVolcano Corporation · 2008 · 2 generations on28descendants
- K082229S5/S5I Series Intravascular Imaging and Pressure System, Combomap Pressure and Flow SystemVolcano Corporation · 2008 · 3 generations on25descendants
- K111706Volcano S5IINTRAVASCULAR Imaging and Pressure SystemVolcano Corporation · 2011 · 4 generations on24descendants
- K123898Volcano S5/S5I Intravascular Ultrasound Imaging and Pressure SystemVolcano Corporation · 2013 · 5 generations on21descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K000820 | Avanar F/X 2.9F Intravascular Ultrasound Imaging Catheter, Model 85700 | Endosonics Corp. | 2000 | — |
| 0 (this device) | K031346 | Jovus Eagle Eye F/X 2.9F Ivus Catheter, Model 85900 | Jomed, Inc. | 2003 | — |
| +1 | K051337 | Eagle Eye Gold Ivus Imaging Catheter, Model 85900/859XX; Volcano VH-Ivus… | Volcano Corporation | 2005 | — |
| +2 | K071554 | Volcano S5/S5I Intravascular Imaging and Pressure System | Volcano Corporation | 2008 | 2 |
| +3 | K082229 | S5/S5I Series Intravascular Imaging and Pressure System, Combomap Pressure and… | Volcano Corporation | 2008 | 3 |
| +4 | K111706 | Volcano S5IINTRAVASCULAR Imaging and Pressure System | Volcano Corporation | 2011 | 1 |
| +5 | K123898 | Volcano S5/S5I Intravascular Ultrasound Imaging and Pressure System | Volcano Corporation | 2013 | 10 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K000820 | Avanar F/X 2.9F Intravascular Ultrasound Imaging Catheter, Model 85700 | 2000 |
What descends from it? (48)
See all 481 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K051337 | Eagle Eye Gold Ivus Imaging Catheter, Model 85900/859XX; Volcano VH-Ivus System, Model… | 2005 | 47 |
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 · 3 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 · 6 generations on · ◆ in the 2020 descendants bar of FIG. 11 Class I recall
What does this lineage say?
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?
JOVUS Eagle Eye F/X catheters are designed for use in the evaluation of vascular morphology 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.
JOVUS Eagle Eye F/X 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031346 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031346: Jovus Eagle Eye F/X 2.9F Ivus Catheter, Model 85900.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031346
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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