510(k) · Cleared
Recalled · Class II · 2017Volcano S5/S5I Intravascular Imaging and Pressure System
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 Jan 4, 2008 as substantially equivalent to K061215 (Volcano Corporation, 2006) and 15 other predicates after a 211-day review. Its family tree reaches back 5 generations to 1995. 1 of the 72 devices in its family, counting itself, has a Class I recall. 28 later devices descend from it. It has been recalled 2 times.
- Decided
- Jan 4, 2008
- Review
- 211 days
- Class
- Class II
- Product code
- OBJ
- Recalls
- 2
- Predicates
- 16
Its longest line of descent runs back 5 generations to K934139 (1995). 43 ancestors in all, the oldest K823434 (1982). 28 later devices descend from it, 2 citing it directly. 1 of the 72 devices in this family, counting this one, has a Class I recall.
- Root · 5 generations backK934139 Tomtec Echo-ViewTomtec Tomographic Technologies GmbH · 1995
- 4 generations backK993398 Echo View, Easy View, Omni ViewTomtec Imaging Systems GmbH · 1999
- 3 generations backK022824 Echo-View 5.X, Easy-View 2.X, Omni View 2.X, Cardio-View 1.X, LV…Tomtec Imaging Systems GmbH · 2002
- 2 generations backK042188 Volcano Therapeutics, Inc. Volcano Ivus SystemVolcano Therapeutics, Inc. · 2004
- 1 generation backK051337 Eagle Eye Gold Ivus Imaging Catheter, Model 85900/859XX; Volcano…Volcano Corporation · 2005
- This deviceK071554 Volcano S5/S5I Intravascular Imaging and Pressure SystemVolcano Corporation · 2008
- Descendant · cites it directly · 25 of its ownK082229 S5/S5I Series Intravascular Imaging and Pressure System, Combomap…Volcano Corporation · 2008 · Recalled
- Descendant · 2 generations on · 24 of its ownK111706 Volcano S5IINTRAVASCULAR Imaging and Pressure SystemVolcano Corporation · 2011 · Recalled
- Descendant · 3 generations on · 21 of its ownK123898 Volcano S5/S5I Intravascular Ultrasound Imaging and Pressure SystemVolcano Corporation · 2013 · Recalled
- Descendant · 4 generations on · 18 of its ownK133323 Volcano Ifr ModalityVolcano Corporation · 2014
- Descendant · 5 generations on · 9 of its ownK150441 Volcano iFR Modality, iFR Scout featureVolcano Corporation · 2015
Showing 5 of 28 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K172258 Novasight Hybrid Systemcites it directly · 2018
Most influential descendants
Showing 5 of 28 · See all- K082229S5/S5I Series Intravascular Imaging and Pressure System, Combomap Pressure and Flow SystemVolcano Corporation · 2008 · cites it directly25descendants
- K111706Volcano S5IINTRAVASCULAR Imaging and Pressure SystemVolcano Corporation · 2011 · 2 generations on24descendants
- K123898Volcano S5/S5I Intravascular Ultrasound Imaging and Pressure SystemVolcano Corporation · 2013 · 3 generations on21descendants
- K133323Volcano Ifr ModalityVolcano Corporation · 2014 · 4 generations on18descendants
- K150441Volcano iFR Modality, iFR Scout featureVolcano Corporation · 2015 · 5 generations on9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K934139 | Tomtec Echo-View | Tomtec Tomographic Technologies GmbH | 1995 | — |
| −4 | K993398 | Echo View, Easy View, Omni View | Tomtec Imaging Systems GmbH | 1999 | — |
| −3 | 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 | — |
| −2 | K042188 | Volcano Therapeutics, Inc. Volcano Ivus System | Volcano Therapeutics, Inc. | 2004 | — |
| −1 | K051337 | Eagle Eye Gold Ivus Imaging Catheter, Model 85900/859XX; Volcano VH-Ivus… | Volcano Corporation | 2005 | — |
| 0 (this device) | K071554 | Volcano S5/S5I Intravascular Imaging and Pressure System | Volcano Corporation | 2008 | — |
| +1 | K082229 | S5/S5I Series Intravascular Imaging and Pressure System, Combomap Pressure and… | Volcano Corporation | 2008 | 3 |
| +2 | K111706 | Volcano S5IINTRAVASCULAR Imaging and Pressure System | Volcano Corporation | 2011 | 1 |
| +3 | K123898 | Volcano S5/S5I Intravascular Ultrasound Imaging and Pressure System | Volcano Corporation | 2013 | 10 |
| +4 | K133323 | Volcano Ifr Modality | Volcano Corporation | 2014 | — |
| +5 | K150441 | Volcano iFR Modality, iFR Scout feature | Volcano Corporation | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1986 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 5 | 0 |
| 1993 | 3 | 0 |
| 1994 | 3 | 0 |
| 1995 | 2 | 0 |
| 1996 | 3 | 0 |
| 1997 | 3 | 0 |
| 1998 | 3 | 0 |
| 2000 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
| 2005 | 3 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 4 | 0 |
| 2014 | 1 | 0 |
| 2015 | 3 | 0 |
| 2017 | 3 | 0 |
| 2018 | 2 | 1 |
| 2019 | 4 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 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.
1 device in this family has 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? (16)
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 |
|---|---|---|---|
| * | K061215 | Volcano S51 Family of Imaging SystemsSummary page 2…Catheters/Wires Numbers Name Clearance 510(k) Clearance Volcano s5i K061215 s5/806300-001 K051337 85900 Eagle Eye Gold Family of s5/806300-003 K000820… | 2006 |
| * | K051920 | Volcano S5 Imaging System, Model 804200-001Summary page 2…K944004 86700 PV 0.018 Systems K902329 88900 PV8.2 Volcano s5 K051920 s5/804200-001 K051337 85900 Eagle Eye Gold Imaging K000820… | 2005 |
| * | K041134 | Combomap Pressure and Flow SystemSummary page 2…K944004 86700 PV 0.018 K902329 88900 PV8.2 ComboMapK K041134 6800 K021219 SmartWire II/BrightWire II Pressure K0704… | 2004 |
| * | K051337 | Eagle Eye Gold Ivus Imaging Catheter, Model 85900/859XX; Volcano VH-Ivus System, Model…Summary page 2…me Clearance 510(k) Clearance Volcano s5i K061215 s5/806300-001 K051337 85900 Eagle Eye Gold Family of s5/806300-003 K000820 85700 Avanar FX 2.9F Im… | 2005 |
| * | K052348 | IN Vision Gold with Spin Vision, Model 891 SVSummary page 2…gle Eye Gold System 804907-001 804908-001 804911-001 In-Vision K052348 804906-001 K050995 89000 Revolution Gold with 804907-001 K051337… | 2005 |
| * | K000820 | Avanar F/X 2.9F Intravascular Ultrasound Imaging Catheter, Model 85700Summary page 2…Clearance Volcano s5i K061215 s5/806300-001 K051337 85900 Eagle Eye Gold Family of s5/806300-003 K000820 85700 Avanar FX 2.9F Imaging K944004 86700 PV 0.018 Systems… | 2000 |
| * | K944004 | Visions 2.9F Ultrasonic Imaging Catheter (Model 84300)Summary page 2…85900 Eagle Eye Gold Family of s5/806300-003 K000820 85700 Avanar FX 2.9F Imaging K944004 86700 PV 0.018 Systems K902329 88900 PV8.2 Volcano s5 K0… | 1995 |
| * | K902329 | Ultra-VU AngioscopeSummary page 2…85700 Avanar FX 2.9F Imaging K944004 86700 PV 0.018 Systems K902329 88900 PV8.2 Volcano s5 K051920 s5/804200-001 K051337 85900 Eagle Eye Gold Imaging… | 1990 |
| * | K021219 | Smartwire/Smartmap Pressure SystemSummary page 2…K944004 86700 PV 0.018 K902329 88900 PV8.2 ComboMapK K041134 6800 K021219 SmartWire II/BrightWire II Pressure K070487 6600, 6600J, 6603,… | 2002 |
| * | K070487 | Smartwire Pressure Guide Wire, Model 66XXSummary page 2…88900 PV8.2 ComboMapK K041134 6800 K021219 SmartWire II/BrightWire II Pressure K070487 6600, 6600J, 6603, and Flow 6603J, 6613, 6613J System… | 2007 |
| * | K042996 | Combowire Pressure and Flow Guide Wire, Combotip Pressure and Flow Guide WireSummary page 2…6603J, 6613, 6613J System (7600, 7600J, 7603, K042996 7603J) FloWire… | 2004 |
| * | K050995 | Revolution 45 MHZ Rotational Ivus Imaging CatheterSummary page 2…804907-001 804908-001 804911-001 In-Vision K052348 804906-001 K050995 89000 Revolution Gold with 804907-001 K051337 85900 Eagle Eye Gold SpinVi… | 2005 |
| * | K965140 | Cardiometrics Wavewire/Wavemap Pressure SystemSummary page 2…K944004 86700 PV 0.018 K902329 88900 PV8.2 Other prior predicates: WaveMap cleared under K965140; SmartMap cleared under K021219; ColorFlo Option for the Oracle InVision Intravascular Ultrasound Imaging System cleared under K9… | 1997 |
| * | K963290 | Colorflo Option for the Oracle Invision Intravascular Ultrasonic Imaging SystemSummary page 2…predicates: WaveMap cleared under K965140; SmartMap cleared under K021219; ColorFlo Option for the Oracle InVision Intravascular Ultrasound Imaging System cleared under K963290 on August 6, 1997; the Resolve Option for the Oracle InVision Intravascular Ultrasound Imaging System cleared under K965223 on Ju… | 1997 |
| * | K965223 | Resolve Option for the Oracle in Vision Intravascular Ultrasonic Imaging SystemSummary page 2…cular Ultrasound Imaging System cleared under K963290 on August 6, 1997; the Resolve Option for the Oracle InVision Intravascular Ultrasound Imaging System cleared under K965223 on June 29, 1998, the InVision Imaging System cleared under K031148 on May 28, 2003. NOTE: Volcano Therapeutics, Inc. (now Volca… | 1998 |
| * | K031148 | IN-Vision Imaging SystemSummary page 2…997; the Resolve Option for the Oracle InVision Intravascular Ultrasound Imaging System cleared under K965223 on June 29, 1998, the InVision Imaging System cleared under K031148 on May 28, 2003. NOTE: Volcano Therapeutics, Inc. (now Volcano Corporation)purchasedthe assets of JOMED Inc. on July 21, 2003. J… | 2003 |
What descends from it? (28)
See all 282 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 3, 2017 | Class II | Z-0189-2018 | Software design | On certain Impacted Systems, an unexpected Microsoft Windows Security dialog may appear during use, and the users response to the dialog may adversely affect the subsequent operation of the device. |
| Apr 25, 2016 | Class II | Z-1813-2016 | Software in the Use Environment | Volcano has become aware of an incompatibility issue between Impacted Systems and hospital network scans. In specific circumstances, an impacted System will encounter unexpected data from the hospital network and be forced to reboot |
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 · Cites it directly · ◆ in the 2018 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 13 years and passes through 4 companies; a new generation was cleared every 2.4 years on median.
- 2 of the 43 ancestors have a recall of any class.
- Of its descendants, K082229 (Volcano Corporation, 2008) has gone furthest, with 25 descendants of its own.
- 3 other devices also cite its predicate K061215.
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 Volcano s5/s5i Series Intravascular Imaging and Pressure System is used for the qualitative and quantitative evaluation of vascular morphology in the coronary arteries and vessels of the peripheral vasculature. It is also indicated as an adjunct to conventional angiographic procedures to provide an image of vessel lumen and wall structures. ChromaFlo® is indicated for qualitative blood flow information from peripheral and coronary vasculature; flow…
Read the full statement (225 words)
The Volcano s5/s5i Series Intravascular Imaging and Pressure System is used for the qualitative and quantitative evaluation of vascular morphology in the coronary arteries and vessels of the peripheral vasculature. It is also indicated as an adjunct to conventional angiographic procedures to provide an image of vessel lumen and wall structures.
ChromaFlo® is indicated for qualitative blood flow information from peripheral and coronary vasculature; flow information can be an adjunct to other methods of estimating blood flow and blood perfusion.
VH IVUS 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 features that the user may wish to examine more closely during routine diagnostic ultrasound imaging examinations.
The pressure feature is intended for use in all blood vessels, including coronary and peripheral arteries, to measure intravascular blood pressure during diagnostic angiography and/or interventional procedures.
Rotational 45MHz feature is intended for the qualitative and quantitative evaluation of vascular morphology in the coronary arteries and vasculature. As an adjunct to conventional angiographic procedures to provide an image of the vessel lumen and wall structures. The pullback feature of the PIMr withdraws the imaging core within the protective sheath for a maximum of 15 cm.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071554 · printed Nov 5, 2026
Cite this page
510(k) Report. “K071554: Volcano S5/S5I Intravascular Imaging and Pressure System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K071554
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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