510(k) · Cleared
Recalled · Class II · 2017REFINITY Rotational IVUS Catheter, REFINITY Rotational IVUS Catheter, Short Tip
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 Oct 26, 2016 as substantially equivalent to K080891 (Volcano Corporation, 2008) and 1 other predicate after a 239-day review. Its family tree reaches back 8 generations to 1995. It has been recalled 2 times.
- Decided
- Oct 26, 2016
- Review
- 239 days
- Class
- Class II
- Product code
- OBJ
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 8 generations to K934139 (1995). 18 ancestors in all, the oldest K921879 (1992). No later device cites it as a predicate yet.
- Root · 8 generations backK934139 Tomtec Echo-ViewTomtec Tomographic Technologies GmbH · 1995
- 7 generations backK993398 Echo View, Easy View, Omni ViewTomtec Imaging Systems GmbH · 1999
- 6 generations backK022824 Echo-View 5.X, Easy-View 2.X, Omni View 2.X, Cardio-View 1.X, LV…Tomtec Imaging Systems GmbH · 2002
- 5 generations backK042188 Volcano Therapeutics, Inc. Volcano Ivus SystemVolcano Therapeutics, Inc. · 2004
- 4 generations backK051337 Eagle Eye Gold Ivus Imaging Catheter, Model 85900/859XX; Volcano…Volcano Corporation · 2005
- 3 generations backK073473 Eagle Eye Gold Ivus Imaging Catheter, Model 85900, Avabar F/X Ivus…Volcano Corporation · 2008
- 2 generations backK092596 Eagle Eye Platinum Digital Ivus CatheterVolcano Corporation · 2009
- 1 generation backK120697 Eagle Eye Platinum ST CatheterVolcano Corporation · 2012
- This deviceK160583 REFINITY Rotational IVUS Catheter, REFINITY Rotational IVUS…Volcano Corporation · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K934139 | Tomtec Echo-View | Tomtec Tomographic Technologies GmbH | 1995 | — |
| −7 | K993398 | Echo View, Easy View, Omni View | Tomtec Imaging Systems GmbH | 1999 | — |
| −6 | 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 | — |
| −5 | K042188 | Volcano Therapeutics, Inc. Volcano Ivus System | Volcano Therapeutics, Inc. | 2004 | — |
| −4 | K051337 | Eagle Eye Gold Ivus Imaging Catheter, Model 85900/859XX; Volcano VH-Ivus… | Volcano Corporation | 2005 | — |
| −3 | K073473 | Eagle Eye Gold Ivus Imaging Catheter, Model 85900, Avabar F/X Ivus Imaging… | Volcano Corporation | 2008 | — |
| −2 | K092596 | Eagle Eye Platinum Digital Ivus Catheter | Volcano Corporation | 2009 | — |
| −1 | K120697 | Eagle Eye Platinum ST Catheter | Volcano Corporation | 2012 | — |
| 0 (this device) | K160583 | REFINITY Rotational IVUS Catheter, REFINITY Rotational IVUS Catheter, Short Tip | Volcano Corporation | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 2 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2008 | 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 OBJ? 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 |
|---|---|---|---|
| * | K080891 | Revolution 45MHZ Ivus Imaging CatheterSummary page 4…Catheter ModelNumber:89000 ProductCode:OBJ K080891,ClearedonMay12,2008 SecondaryPredicate… | 2008 |
| * | K120697 | Eagle Eye Platinum ST CatheterSummary page 4…ShortTipCatheter ModelNumber:85900PST ProductCode:OBJ,ITX K120697,ClearedonApril5,2012 3721 Valley Centre Drive, Suite 500 | San Diego, CA 92130 | ww… | 2012 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 29, 2017 | Class II | Z-1776-2017 | Under Investigation by firm | High complaint rates of kinking near the junction of the proximal shaft to telescope section of the catheter. Kinking could result in disruption of normal clinical workflow or loss of imaging. |
| Mar 29, 2017 | Class II | Z-1775-2017 | Under Investigation by firm | High complaint rates of kinking near the junction of the proximal shaft to telescope section of the catheter. Kinking could result in disruption of normal clinical workflow or loss of imaging. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 21 years and passes through 4 companies; a new generation was cleared every 2.4 years on median.
- None of the 18 ancestors has a recall.
- 1 other device also cites its predicate K080891.
How does its category compare?
All OBJ devicesOBJ Catheter, Ultrasound, Intravascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
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 REFINITY (or REFINITY ST) Rotational IVUS Catheter (REFINITY or REFINITY ST catheter) is intended for the intravascular ultrasound examination of coronary arteries. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal interventional procedures. REFINITY (or REFINITY ST) 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/K160583 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160583: REFINITY Rotational IVUS Catheter, REFINITY Rotational IVUS Catheter, Short Tip.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160583
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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