510(k) · Cleared
Recalled · Class II · 2017Volcano S5/S5I Intravascular Ultrasound Imaging and Pressure System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Volcano Corporation · IYO System, Imaging, Pulsed Echo, Ultrasonic
Cleared on Jan 14, 2013 as substantially equivalent to K111706 (Volcano Corporation, 2011) after a 27-day review. Its family tree reaches back 8 generations to 1995. 21 later devices descend from it. It has been recalled 10 times.
- Decided
- Jan 14, 2013
- Review
- 27 days
- Class
- Class II
- Product code
- IYO
- Recalls
- 10
- Predicates
- 2
Its longest line of descent runs back 8 generations to K934139 (1995). 46 ancestors in all, the oldest K823434 (1982). 21 later devices descend from it, 3 citing it directly.
- 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 backK071554 Volcano S5/S5I Intravascular Imaging and Pressure SystemVolcano Corporation · 2008 · Recalled
- 2 generations backK082229 S5/S5I Series Intravascular Imaging and Pressure System, Combomap…Volcano Corporation · 2008 · Recalled
- 1 generation backK111706 Volcano S5IINTRAVASCULAR Imaging and Pressure SystemVolcano Corporation · 2011 · Recalled
- This deviceK123898 Volcano S5/S5I Intravascular Ultrasound Imaging and Pressure SystemVolcano Corporation · 2013
- Descendant · cites it directly · 18 of its ownK133323 Volcano Ifr ModalityVolcano Corporation · 2014
- Descendant · 2 generations on · 9 of its ownK150441 Volcano iFR Modality, iFR Scout featureVolcano Corporation · 2015
- Descendant · 3 generations on · 5 of its ownK170133 FFR V2.5Philips Volcano · 2017 · Recalled
- Descendant · 2 generations on · 4 of its ownK173860 s5 Intravascular Ultrasound Imaging and Pressure Systems, s5i…Volcano Corporation · 2018
- Descendant · 2 generations on · 3 of its ownK183099 QUANTIEN Measurement SystemSt. Jude Medical (Now Abbott Medical) · 2019
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 21 · See all- K133323Volcano Ifr ModalityVolcano Corporation · 2014 · cites it directly18descendants
- K150441Volcano iFR Modality, iFR Scout featureVolcano Corporation · 2015 · 2 generations on9descendants
- K170133FFR V2.5Philips Volcano · 2017 · 3 generations on5descendants
- K173860s5 Intravascular Ultrasound Imaging and Pressure Systems, s5i Intravascular Ultrasound…Volcano Corporation · 2018 · 2 generations on4descendants
- K183099QUANTIEN Measurement SystemSt. Jude Medical (Now Abbott Medical) · 2019 · 2 generations on3descendants
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 | 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 |
| −1 | K111706 | Volcano S5IINTRAVASCULAR Imaging and Pressure System | Volcano Corporation | 2011 | 1 |
| 0 (this device) | K123898 | Volcano S5/S5I Intravascular Ultrasound Imaging and Pressure System | Volcano Corporation | 2013 | — |
| +1 | K133323 | Volcano Ifr Modality | Volcano Corporation | 2014 | — |
| +2 | K150441 | Volcano iFR Modality, iFR Scout feature | Volcano Corporation | 2015 | — |
| +3 | K170133 | FFR V2.5 | Philips Volcano | 2017 | 1 |
| +2 | K173860 | s5 Intravascular Ultrasound Imaging and Pressure Systems, s5i Intravascular… | Volcano Corporation | 2018 | — |
| +2 | K183099 | QUANTIEN Measurement System | St. Jude Medical (Now Abbott Medical) | 2019 | — |
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 |
|---|---|---|
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 3 | 0 |
| 2017 | 3 | 0 |
| 2018 | 1 | 0 |
| 2019 | 4 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 IYO? 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 IYO device
- #1 K243937 Accuro 3Sscore 20.5 · 18 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K111706 | Volcano S5IINTRAVASCULAR Imaging and Pressure System | 2011 |
| Kept off the family tree | K113486 | FDA’s K113486 is Volcano S5I Intravascular Ultracound Imaging and Pressure System Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2012 |
What descends from it? (21)
See all 213 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)
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 |
| Jun 22, 2015 | Class II | Z-2135-2015 | Software design | A software issue was discovered where an inaccurate FFR/iFR value could be calculated under certain circumstances. |
| Jun 22, 2015 | Class II | Z-2132-2015 | Software design | A software issue was discovered where an inaccurate FFR/iFR value could be calculated under certain circumstances. |
| Jun 22, 2015 | Class II | Z-2134-2015 | Software design | A software issue was discovered where an inaccurate FFR/iFR value could be calculated under certain circumstances. |
| Jun 22, 2015 | Class II | Z-2131-2015 | Software design | A software issue was discovered where an inaccurate FFR/iFR value could be calculated under certain circumstances. |
| Jun 22, 2015 | Class II | Z-2136-2015 | Software design | A software issue was discovered where an inaccurate FFR/iFR value could be calculated under certain circumstances. |
| Jun 22, 2015 | Class II | Z-2133-2015 | Software design | A software issue was discovered where an inaccurate FFR/iFR value could be calculated under certain circumstances. |
| Sep 23, 2013 | Class II | Z-2043-2015 | Nonconforming Material/Component | A limitation in interoperability between the Philips Xper Flex Cardia Physiomonitoring System and Volcano's sS/Si, Core, and ComboMap systems. This limitation may impact the calculation of Fraction Flow Reserve (FFR) within the Volcano… |
| Sep 23, 2013 | Class II | Z-2044-2015 | Nonconforming Material/Component | A limitation in interoperability between the Philips Xper Flex Cardia Physiomonitoring System and Volcano's sS/Si, Core, and ComboMap systems. This limitation may impact the calculation of Fraction Flow Reserve (FFR) within the Volcano… |
The 5 latest of 10 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 18 years and passes through 4 companies; a new generation was cleared every 2.4 years on median.
- 5 of the 46 ancestors have a recall of any class.
- Of its descendants, K133323 (Volcano Corporation, 2014) has gone furthest, with 18 descendants of its own.
- 1 other device also cites its predicate K111706.
How does its category compare?
All IYO devicesIYO System, Imaging, Pulsed Echo, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · IYO
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IYO
171in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYO
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IYO
485in 2025
MAUDE reports naming product code IYO, 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 | 20 | 17 | 4 | 39 |
| 2008 | 14 | 36 | 5 | 20 |
| 2009 | 13 | 79 | 9 | 27 |
| 2010 | 15 | 113 | 8 | 20 |
| 2011 | 11 | 69 | 0 | 58 |
| 2012 | 15 | 68 | 2 | 78 |
| 2013 | 17 | 50 | 3 | 436 |
| 2014 | 14 | 63 | 2 | 304 |
| 2015 | 19 | 46 | 1 | 268 |
| 2016 | 10 | 36 | 0 | 254 |
| 2017 | 19 | 72 | 0 | 238 |
| 2018 | 14 | 56 | 1 | 368 |
| 2019 | 13 | 59 | 1 | 537 |
| 2020 | 11 | 57 | 0 | 498 |
| 2021 | 15 | 64 | 11 | 617 |
| 2022 | 5 | 190 | 1 | 511 |
| 2023 | 11 | 177 | 0 | 527 |
| 2024 | 10 | 220 | 0 | 640 |
| 2025 | 7 | 171 | 0 | 485 |
| 2026 | 10 | 139 | 1 | — |
What is it indicated for?
The Volcano s5TM/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…
Read the full statement (225 words)
The Volcano s5TM/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 vasculatufe. The Volcano VH IV-US System is intended to semi-automatically visualize boundary features and perform spectral analysis of RIF 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/K123898 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123898: Volcano S5/S5I Intravascular Ultrasound Imaging and Pressure System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123898
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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