510(k) · Cleared
Recalled · Class II · 2013S5/S5I Series Intravascular Imaging and Pressure System, Combomap Pressure and Flow 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 Oct 8, 2008 as substantially equivalent to K071554 (Volcano Corporation, 2008) and 6 other predicates after a 62-day review. Its family tree reaches back 6 generations to 1995. 25 later devices descend from it. It has been recalled 3 times.
- Decided
- Oct 8, 2008
- Review
- 62 days
- Class
- Class II
- Product code
- IYO
- Recalls
- 3
- Predicates
- 7
Its longest line of descent runs back 6 generations to K934139 (1995). 44 ancestors in all, the oldest K823434 (1982). 25 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK934139 Tomtec Echo-ViewTomtec Tomographic Technologies GmbH · 1995
- 5 generations backK993398 Echo View, Easy View, Omni ViewTomtec Imaging Systems GmbH · 1999
- 4 generations backK022824 Echo-View 5.X, Easy-View 2.X, Omni View 2.X, Cardio-View 1.X, LV…Tomtec Imaging Systems GmbH · 2002
- 3 generations backK042188 Volcano Therapeutics, Inc. Volcano Ivus SystemVolcano Therapeutics, Inc. · 2004
- 2 generations backK051337 Eagle Eye Gold Ivus Imaging Catheter, Model 85900/859XX; Volcano…Volcano Corporation · 2005
- 1 generation backK071554 Volcano S5/S5I Intravascular Imaging and Pressure SystemVolcano Corporation · 2008 · Recalled
- This deviceK082229 S5/S5I Series Intravascular Imaging and Pressure System, Combomap…Volcano Corporation · 2008
- Descendant · cites it directly · 24 of its ownK111706 Volcano S5IINTRAVASCULAR Imaging and Pressure SystemVolcano Corporation · 2011 · Recalled
- Descendant · 2 generations on · 21 of its ownK123898 Volcano S5/S5I Intravascular Ultrasound Imaging and Pressure SystemVolcano Corporation · 2013 · Recalled
- Descendant · 3 generations on · 18 of its ownK133323 Volcano Ifr ModalityVolcano Corporation · 2014
- Descendant · 4 generations on · 9 of its ownK150441 Volcano iFR Modality, iFR Scout featureVolcano Corporation · 2015
- Descendant · 5 generations on · 5 of its ownK170133 FFR V2.5Philips Volcano · 2017 · Recalled
Showing 5 of 25 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 25 · See all- K111706Volcano S5IINTRAVASCULAR Imaging and Pressure SystemVolcano Corporation · 2011 · cites it directly24descendants
- K123898Volcano S5/S5I Intravascular Ultrasound Imaging and Pressure SystemVolcano Corporation · 2013 · 2 generations on21descendants
- K133323Volcano Ifr ModalityVolcano Corporation · 2014 · 3 generations on18descendants
- K150441Volcano iFR Modality, iFR Scout featureVolcano Corporation · 2015 · 4 generations on9descendants
- K170133FFR V2.5Philips Volcano · 2017 · 5 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K934139 | Tomtec Echo-View | Tomtec Tomographic Technologies GmbH | 1995 | — |
| −5 | K993398 | Echo View, Easy View, Omni View | Tomtec Imaging Systems GmbH | 1999 | — |
| −4 | 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 | — |
| −3 | K042188 | Volcano Therapeutics, Inc. Volcano Ivus System | Volcano Therapeutics, Inc. | 2004 | — |
| −2 | K051337 | Eagle Eye Gold Ivus Imaging Catheter, Model 85900/859XX; Volcano VH-Ivus… | Volcano Corporation | 2005 | — |
| −1 | K071554 | Volcano S5/S5I Intravascular Imaging and Pressure System | Volcano Corporation | 2008 | 2 |
| 0 (this device) | K082229 | S5/S5I Series Intravascular Imaging and Pressure System, Combomap Pressure and… | Volcano Corporation | 2008 | — |
| +1 | K111706 | Volcano S5IINTRAVASCULAR Imaging and Pressure System | Volcano Corporation | 2011 | 1 |
| +2 | K123898 | Volcano S5/S5I Intravascular Ultrasound Imaging and Pressure System | Volcano Corporation | 2013 | 10 |
| +3 | K133323 | Volcano Ifr Modality | Volcano Corporation | 2014 | — |
| +4 | K150441 | Volcano iFR Modality, iFR Scout feature | Volcano Corporation | 2015 | — |
| +5 | K170133 | FFR V2.5 | Philips Volcano | 2017 | 1 |
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 |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 4 | 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? (7)
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 |
|---|---|---|---|
| * | K071554 | Volcano S5/S5I Intravascular Imaging and Pressure SystemSummary page 2…Volcano s5/s~~~~i Series ~~s5/807300-001 Intravascular and ImagingK071554 s5i1807400-001 ComboMapR Pressure and Flow K041134 6800… | 2008 |
| * | K041134 | Combomap Pressure and Flow SystemSummary page 2…Intravascular and ImagingK071554 s5i1807400-001 ComboMapR Pressure and Flow K041134 6800 System Other prior predicates: WaveMap cleared under K965140; SmartMap cleared under… | 2004 |
| * | K965140 | Cardiometrics Wavewire/Wavemap Pressure SystemSummary page 2…s5i1807400-001 ComboMapR Pressure and Flow K041134 6800 System 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 |
| * | K021219 | Smartwire/Smartmap Pressure SystemSummary page 2…ressure and Flow K041134 6800 System Other prior 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 Res… | 2002 |
| * | 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) purchased the assets of JOMED Inc. on July 21, 2003.… | 2003 |
What descends from it? (25)
See all 251 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K111706 | Volcano S5IINTRAVASCULAR Imaging and Pressure System | 2011 | 24 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 23, 2013 | Class II | Z-2045-2015 | 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… |
| Aug 24, 2012 | Class II | Z-2345-2012 | Software design | The display on the system has the potential to change. In house testing eventually identified the unique sequence of events that must occur in order for this issue to manifest itself. |
| Jun 29, 2010 | Not classified | Z-0168-2011 | Software design | Software defect results in improper image brightness, which may result in introduction of artifacts, which may cause misclassification of results and affect classification of tissue types. This may result in misdiagnosis and inappropriate… |
No ancestor or descendant has a 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.
- 3 of the 44 ancestors have a recall of any class.
- Of its descendants, K111706 (Volcano Corporation, 2011) has gone furthest, with 24 descendants of its own.
- 1 other device also cites its predicate K071554.
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. 2008, 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 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 (261 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.
ComboMapTM Pressure and Flow System is a multi-mode system intended for use in all blood vessels, including coronary and peripheral arteries, to measure intravascular blood pressure and/or blood flow velocities during diagnostic angiography and/or interventional procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082229 · printed Nov 4, 2026
Cite this page
510(k) Report. “K082229: S5/S5I Series Intravascular Imaging and Pressure System, Combomap Pressure and Flow System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K082229
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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