510(k) · Cleared
ClearedVolcano Core Control Pad, Accessory to the Volcano S5/S5I Intravascular Ultrasound Imaging & Pressure Systems
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 Mar 7, 2014 as substantially equivalent to K133641 (Volcano Corporation, 2013) after a 30-day review. Its family tree reaches back 1 generation to 2013. 3 later devices descend from it.
- Decided
- Mar 7, 2014
- Review
- 30 days
- Class
- Class II
- Product code
- IYO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K133641 (2013). 3 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK133641 Core Control Pad, Core Series SW V3.4 Installation Kit, Core, Core…Volcano Corporation · 2013
- This deviceK140291 Volcano Core Control Pad, Accessory to the Volcano S5/S5I…Volcano Corporation · 2014
- Descendant · cites it directly · 2 of its ownK153369 SW v3.5 Install Kit, CORE Mobile, SW v3.5 Install Kit, CORE, SW v3.5…Volcano Corporation · 2015
- Descendant · 2 generations on · 1 of its ownK170385 CORE M2 Vascular SystemVolcano Corporation · 2017
- Descendant · 2 generations on · 0 of its ownK172455 CORE M2 Vascular System, CORE M2 Software v4.2 Upgrade Kit, CORE M2…Volcano Corporation · 2017 · Recalled
Most influential descendants
Showing 3 of 3 · See all- K153369SW v3.5 Install Kit, CORE Mobile, SW v3.5 Install Kit, CORE, SW v3.5 Install Kit, s5izVolcano Corporation · 2015 · cites it directly2descendants
- K170385CORE M2 Vascular SystemVolcano Corporation · 2017 · 2 generations on1descendant
- K172455CORE M2 Vascular System, CORE M2 Software v4.2 Upgrade Kit, CORE M2 Software v4.2…Volcano Corporation · 2017 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K133641 | Core Control Pad, Core Series SW V3.4 Installation Kit, Core, Core Mobile | Volcano Corporation | 2013 | — |
| 0 (this device) | K140291 | Volcano Core Control Pad, Accessory to the Volcano S5/S5I Intravascular… | Volcano Corporation | 2014 | — |
| +1 | K153369 | SW v3.5 Install Kit, CORE Mobile, SW v3.5 Install Kit, CORE, SW v3.5 Install… | Volcano Corporation | 2015 | — |
| +2 | K170385 | CORE M2 Vascular System | Volcano Corporation | 2017 | — |
| +2 | K172455 | CORE M2 Vascular System, CORE M2 Software v4.2 Upgrade Kit, CORE M2 Software… | Volcano Corporation | 2017 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2017 | 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.
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 |
|---|---|---|---|
| * | K133641 | Core Control Pad, Core Series SW V3.4 Installation Kit, Core, Core MobileSummary page 1…d Pressure Coinputer 11 DSK 870.2900 Patient Transducer and Electrical Cable I] DSA PREDICATE DEVICE: K 133641, Volcano CORETM and CORE"" Mobile Series Precision Guided Therapy Systems DEVICE DESCRIPTION: The Volcano s5 Series Intravascula… | 2013 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K153369 | SW v3.5 Install Kit, CORE Mobile, SW v3.5 Install Kit, CORE, SW v3.5 Install Kit, s5iz | 2015 | 2 |
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?
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. 2014, 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 S5T f S5j6 Series Intravascular Ultrasound Imaging and Pressure Systems 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 lumnen and wall structures. ChromaFlo®& is indicated for qualitative blood flow information from peripheral and coronary…
Read the full statement (227 words)
The Volcano S5T f S5j6 Series Intravascular Ultrasound Imaging and Pressure Systems 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 lumnen 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®D IVUS 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/K140291 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140291: Volcano Core Control Pad, Accessory to the Volcano S5/S5I Intravascular Ultrasound Imaging & Pressure Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140291
Report an extraction error
Are you the manufacturer?
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