510(k) · Cleared
ClearedVolcano Lomap,Volcano Lomap Option Kit for Mobile System,Volcano Lomap Option for Integrated System,Volcano S5 Precision
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 Nov 15, 2013 as substantially equivalent to K123898 (Volcano Corporation, 2013) after a 29-day review. Its family tree reaches back 9 generations to 1995.
- Decided
- Nov 15, 2013
- Review
- 29 days
- Class
- Class II
- Product code
- IYO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K934139 (1995). 47 ancestors in all, the oldest K823434 (1982). No later device cites it as a predicate yet.
- Root · 9 generations backK934139 Tomtec Echo-ViewTomtec Tomographic Technologies GmbH · 1995
- 5 generations between
- 3 generations backK082229 S5/S5I Series Intravascular Imaging and Pressure System, Combomap…Volcano Corporation · 2008 · Recalled
- 2 generations backK111706 Volcano S5IINTRAVASCULAR Imaging and Pressure SystemVolcano Corporation · 2011 · Recalled
- 1 generation backK123898 Volcano S5/S5I Intravascular Ultrasound Imaging and Pressure SystemVolcano Corporation · 2013 · Recalled
- This deviceK133142 Volcano Lomap,Volcano Lomap Option Kit for Mobile System,Volcano…Volcano Corporation · 2013
Show all 9 generations
- Root · 9 generations backK934139 Tomtec Echo-ViewTomtec Tomographic Technologies GmbH · 1995
- 8 generations backK993398 Echo View, Easy View, Omni ViewTomtec Imaging Systems GmbH · 1999
- 7 generations backK022824 Echo-View 5.X, Easy-View 2.X, Omni View 2.X, Cardio-View 1.X, LV…Tomtec Imaging Systems GmbH · 2002
- 6 generations backK042188 Volcano Therapeutics, Inc. Volcano Ivus SystemVolcano Therapeutics, Inc. · 2004
- 5 generations backK051337 Eagle Eye Gold Ivus Imaging Catheter, Model 85900/859XX; Volcano…Volcano Corporation · 2005
- 4 generations backK071554 Volcano S5/S5I Intravascular Imaging and Pressure SystemVolcano Corporation · 2008 · Recalled
- 3 generations backK082229 S5/S5I Series Intravascular Imaging and Pressure System, Combomap…Volcano Corporation · 2008 · Recalled
- 2 generations backK111706 Volcano S5IINTRAVASCULAR Imaging and Pressure SystemVolcano Corporation · 2011 · Recalled
- 1 generation backK123898 Volcano S5/S5I Intravascular Ultrasound Imaging and Pressure SystemVolcano Corporation · 2013 · Recalled
- This deviceK133142 Volcano Lomap,Volcano Lomap Option Kit for Mobile System,Volcano…Volcano Corporation · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K934139 | Tomtec Echo-View | Tomtec Tomographic Technologies GmbH | 1995 | — |
| −8 | K993398 | Echo View, Easy View, Omni View | Tomtec Imaging Systems GmbH | 1999 | — |
| −7 | 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 | — |
| −6 | K042188 | Volcano Therapeutics, Inc. Volcano Ivus System | Volcano Therapeutics, Inc. | 2004 | — |
| −5 | K051337 | Eagle Eye Gold Ivus Imaging Catheter, Model 85900/859XX; Volcano VH-Ivus… | Volcano Corporation | 2005 | — |
| −4 | K071554 | Volcano S5/S5I Intravascular Imaging and Pressure System | Volcano Corporation | 2008 | 2 |
| −3 | 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 |
| −1 | K123898 | Volcano S5/S5I Intravascular Ultrasound Imaging and Pressure System | Volcano Corporation | 2013 | 10 |
| 0 (this device) | K133142 | Volcano Lomap,Volcano Lomap Option Kit for Mobile System,Volcano Lomap Option… | Volcano Corporation | 2013 | — |
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 |
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? (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 |
|---|---|---|---|
| * | K123898 | Volcano S5/S5I Intravascular Ultrasound Imaging and Pressure SystemSummary page 1…1I DSK 870.2900 Patient Transducer and Electrical 11 DSA Cable PREDICATE DEVICE: K(123898, Volcano s5 TM s5i®D lntravascular Ultrasound Imaging System DEVICE DESCRIPTION The Volcano s5 and CORE Series Precision Guided T… | 2013 |
What descends from it?
No later submission names this one as a predicate yet.
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 18 years and passes through 4 companies; a new generation was cleared every 2.1 years on median.
- 6 of the 47 ancestors have a recall of any class.
- 2 other devices also cite its predicate K123898.
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 s5™ 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…
Read the full statement (223 words)
The Volcano s5™ 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/K133142 · printed Nov 3, 2026
Cite this page
510(k) Report. “K133142: Volcano Lomap,Volcano Lomap Option Kit for Mobile System,Volcano Lomap Option for Integrated System,Volcano S5 Precision.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K133142
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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