510(k) · Cleared
Recalled · 2007Volcano S5 Imaging System, Model 804200-001
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 Aug 19, 2005 as substantially equivalent to K944004 (Endosonics Corp., 1995) and 3 other predicates after a 35-day review. Its family tree reaches back 2 generations to 1995. 1 of the 619 devices in its family, counting itself, has a Class I recall. 614 later devices descend from it. It has been recalled once.
- Decided
- Aug 19, 2005
- Review
- 35 days
- Class
- Class II
- Product code
- IYO
- Recalls
- 1
- Predicates
- 4
Its longest line of descent runs back 2 generations to K944004 (1995). 4 ancestors in all. 614 later devices descend from it, 2 citing it directly. 1 of the 619 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK944004 Visions 2.9F Ultrasonic Imaging Catheter (Model 84300)Endosonics Corp. · 1995
- 1 generation backK031148 IN-Vision Imaging SystemJomed, Inc. · 2003
- This deviceK051920 Volcano S5 Imaging System, Model 804200-001Volcano Corporation · 2005
- Descendant · cites it directly · 613 of its ownK061215 Volcano S51 Family of Imaging SystemsVolcano Corporation · 2006
- Descendant · 2 generations on · 582 of its ownK083095 Sonixtouch Ultrasound SystemUltrasonix Medical Corporation · 2008
- Descendant · 3 generations on · 569 of its ownK092271 GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3…GE Healthcare · 2009 · Recalled
- Descendant · 4 generations on · 472 of its ownK110943 Logiq E9GE Healthcare · 2011 · Recalled
- Descendant · 5 generations on · 469 of its ownK113690 GE Logiq I, Logiq E and Vivid EGE Healthcare · 2011 · Recalled
Showing 5 of 614 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K172258 Novasight Hybrid System2 generations on · 2018
Most influential descendants
Showing 5 of 614 · See all- K061215Volcano S51 Family of Imaging SystemsVolcano Corporation · 2006 · cites it directly613descendants
- K083095Sonixtouch Ultrasound SystemUltrasonix Medical Corporation · 2008 · 2 generations on582descendants
- K092271GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4GE Healthcare · 2009 · 3 generations on569descendants
- K110943Logiq E9GE Healthcare · 2011 · 4 generations on472descendants
- K113690GE Logiq I, Logiq E and Vivid EGE Healthcare · 2011 · 5 generations on469descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K944004 | Visions 2.9F Ultrasonic Imaging Catheter (Model 84300) | Endosonics Corp. | 1995 | — |
| −1 | K031148 | IN-Vision Imaging System | Jomed, Inc. | 2003 | — |
| 0 (this device) | K051920 | Volcano S5 Imaging System, Model 804200-001 | Volcano Corporation | 2005 | — |
| +1 | K061215 | Volcano S51 Family of Imaging Systems | Volcano Corporation | 2006 | — |
| +2 | K083095 | Sonixtouch Ultrasound System | Ultrasonix Medical Corporation | 2008 | — |
| +3 | K092271 | GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4 | GE Healthcare | 2009 | 1 |
| +4 | K110943 | Logiq E9 | GE Healthcare | 2011 | 2 |
| +5 | K113690 | GE Logiq I, Logiq E and Vivid E | GE Healthcare | 2011 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2008 | 4 | 0 |
| 2009 | 3 | 0 |
| 2010 | 4 | 0 |
| 2011 | 11 | 0 |
| 2012 | 21 | 0 |
| 2013 | 23 | 0 |
| 2014 | 35 | 0 |
| 2015 | 32 | 0 |
| 2016 | 37 | 0 |
| 2017 | 52 | 0 |
| 2018 | 50 | 1 |
| 2019 | 39 | 0 |
| 2020 | 53 | 0 |
| 2021 | 39 | 0 |
| 2022 | 44 | 0 |
| 2023 | 39 | 0 |
| 2024 | 46 | 0 |
| 2025 | 48 | 0 |
| 2026 | 33 | 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 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? (4)
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 |
|---|---|---|---|
| * | K944004 | Visions 2.9F Ultrasonic Imaging Catheter (Model 84300)Summary page 1…Ultrasonic pulsed echo imaging system Number, Product Code: 21 CFR 892.1560, Product Code: LYO Predicate Device: Cathscarmer III Imaging System cleared under K944004; ColorFlo Option for the Oracle InVision Intravascular Ultrasound Imaging System cleared under K963290; Resolve Option for the Or… | 1995 |
| * | K963290 | Colorflo Option for the Oracle Invision Intravascular Ultrasonic Imaging SystemSummary page 1…O Predicate Device: Cathscarmer III Imaging System cleared under K944004; ColorFlo Option for the Oracle InVision Intravascular Ultrasound Imaging System cleared under K963290; Resolve Option for the Oracle InVision Intravascular Ultrasound Imaging System cleared under K965223; and InVision Imaging Syste… | 1997 |
| * | K965223 | Resolve Option for the Oracle in Vision Intravascular Ultrasonic Imaging SystemSummary page 1…acle InVision Intravascular Ultrasound Imaging System cleared under K963290; Resolve Option for the Oracle InVision Intravascular Ultrasound Imaging System cleared under K965223; and InVision Imaging System cleared under K03 1148 Device Description: The Volcano s5 Imaging System consists of the imaging c… | 1998 |
| * | K031148 | IN-Vision Imaging SystemSummary page 1…em cleared under K963290; Resolve Option for the Oracle InVision Intravascular Ultrasound Imaging System cleared under K965223; and InVision Imaging System cleared under K03 1148 Device Description: The Volcano s5 Imaging System consists of the imaging catheter, the patient interface module, and the syste… | 2003 |
What descends from it? (614)
See all 6142 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 |
|---|---|---|---|---|
| Apr 2, 2007 | Not classified | Z-1190-2007 | Other | During emissions testing, it was discovered that the product exceeds emissions limits for electromagnetic compatibility. |
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 · 2 generations on · ◆ in the 2018 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 10 years and passes through 3 companies; a new generation was cleared every 8.1 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K061215 (Volcano Corporation, 2006) has gone furthest, with 613 descendants of its own.
- 4 other devices also cite its predicate K944004.
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.
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 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051920 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051920: Volcano S5 Imaging System, Model 804200-001.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051920
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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