510(k) · Cleared
ClearedRevolution 45MHZ Ivus Imaging Catheter
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 May 12, 2008 as substantially equivalent to K050995 (Volcano Corporation, 2005) after a 42-day review. Its family tree reaches back 3 generations to 1992. 3 later devices descend from it.
- Decided
- May 12, 2008
- Review
- 42 days
- Class
- Class II
- Product code
- OBJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K921879 (1992). 6 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK921879 Cbis Catheter Pull-Back DeviceCardiovascular Imaging Systems, Inc. · 1992
- 2 generations backK974457 Scout 3.2/45 MHZ Coronary Imaging Catheter, Scout 3.2/45 MHZ…Hewlett-Packard Co. · 1998
- 1 generation backK050995 Revolution 45 MHZ Rotational Ivus Imaging CatheterVolcano Corporation · 2005
- This deviceK080891 Revolution 45MHZ Ivus Imaging CatheterVolcano Corporation · 2008
- Descendant · cites it directly · 1 of its ownK122826 Preview Forward-Looking Ivus Catheter and Laptop System; Preview…Volcano Corporation · 2013
- Descendant · cites it directly · 0 of its ownK160583 REFINITY Rotational IVUS Catheter, REFINITY Rotational IVUS…Volcano Corporation · 2016 · Recalled
- Descendant · 2 generations on · 0 of its ownK132659 Volcano Preview Forward-Looking Ivus SystemVolcano Corporation · 2013
Most influential descendants
Showing 3 of 3 · See all- K122826Preview Forward-Looking Ivus Catheter and Laptop System; Preview Catheter Model 87000…Volcano Corporation · 2013 · cites it directly1descendant
- K160583REFINITY Rotational IVUS Catheter, REFINITY Rotational IVUS Catheter, Short TipVolcano Corporation · 2016 · cites it directly0descendants
- K132659Volcano Preview Forward-Looking Ivus SystemVolcano Corporation · 2013 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K921879 | Cbis Catheter Pull-Back Device | Cardiovascular Imaging Systems, Inc. | 1992 | — |
| −2 | K974457 | Scout 3.2/45 MHZ Coronary Imaging Catheter, Scout 3.2/45 MHZ Coronary Imaging… | Hewlett-Packard Co. | 1998 | — |
| −1 | K050995 | Revolution 45 MHZ Rotational Ivus Imaging Catheter | Volcano Corporation | 2005 | — |
| 0 (this device) | K080891 | Revolution 45MHZ Ivus Imaging Catheter | Volcano Corporation | 2008 | — |
| +1 | K122826 | Preview Forward-Looking Ivus Catheter and Laptop System; Preview Catheter… | Volcano Corporation | 2013 | — |
| +1 | K160583 | REFINITY Rotational IVUS Catheter, REFINITY Rotational IVUS Catheter, Short Tip | Volcano Corporation | 2016 | 2 |
| +2 | K132659 | Volcano Preview Forward-Looking Ivus System | Volcano Corporation | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 2 | 0 |
| 2016 | 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? (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 |
|---|---|---|---|
| * | K050995 | Revolution 45 MHZ Rotational Ivus Imaging CatheterSummary page 1…II Predicate Device: The Revolution® 45 MHz Rotational Imaging Catheter is substantially equivalent to the Revolution® 45 MHz Rotational Imaging Catheter cleared under K050995 on 06120/2005. Intended Use: The Revolution® 45 MHz Rotational IVUS Imaging Catheter is intended for ultrasound examination of c… | 2005 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 16 years and passes through 3 companies; a new generation was cleared every 6.0 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K122826 (Volcano Corporation, 2013) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K050995.
How does its category compare?
All OBJ devicesOBJ Catheter, Ultrasound, Intravascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 Revolution 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080891 · printed Nov 3, 2026
Cite this page
510(k) Report. “K080891: Revolution 45MHZ Ivus Imaging Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K080891
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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