510(k) · Cleared
ClearedVolcano iFR Harvest Software (Offline)
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 Feb 20, 2015 as substantially equivalent to K133323 (Volcano Corporation, 2014) after a 112-day review. Its family tree reaches back 10 generations to 1995.
- Decided
- Feb 20, 2015
- Review
- 112 days
- Class
- Class II
- Product code
- IYO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K934139 (1995). 48 ancestors in all, the oldest K823434 (1982). No later device cites it as a predicate yet.
- Root · 10 generations backK934139 Tomtec Echo-ViewTomtec Tomographic Technologies GmbH · 1995
- 6 generations between
- 3 generations backK111706 Volcano S5IINTRAVASCULAR Imaging and Pressure SystemVolcano Corporation · 2011 · Recalled
- 2 generations backK123898 Volcano S5/S5I Intravascular Ultrasound Imaging and Pressure SystemVolcano Corporation · 2013 · Recalled
- 1 generation backK133323 Volcano Ifr ModalityVolcano Corporation · 2014
- This deviceK143122 Volcano iFR Harvest Software (Offline)Volcano Corporation · 2015
Show all 10 generations
- Root · 10 generations backK934139 Tomtec Echo-ViewTomtec Tomographic Technologies GmbH · 1995
- 9 generations backK993398 Echo View, Easy View, Omni ViewTomtec Imaging Systems GmbH · 1999
- 8 generations backK022824 Echo-View 5.X, Easy-View 2.X, Omni View 2.X, Cardio-View 1.X, LV…Tomtec Imaging Systems GmbH · 2002
- 7 generations backK042188 Volcano Therapeutics, Inc. Volcano Ivus SystemVolcano Therapeutics, Inc. · 2004
- 6 generations backK051337 Eagle Eye Gold Ivus Imaging Catheter, Model 85900/859XX; Volcano…Volcano Corporation · 2005
- 5 generations backK071554 Volcano S5/S5I Intravascular Imaging and Pressure SystemVolcano Corporation · 2008 · Recalled
- 4 generations backK082229 S5/S5I Series Intravascular Imaging and Pressure System, Combomap…Volcano Corporation · 2008 · Recalled
- 3 generations backK111706 Volcano S5IINTRAVASCULAR Imaging and Pressure SystemVolcano Corporation · 2011 · Recalled
- 2 generations backK123898 Volcano S5/S5I Intravascular Ultrasound Imaging and Pressure SystemVolcano Corporation · 2013 · Recalled
- 1 generation backK133323 Volcano Ifr ModalityVolcano Corporation · 2014
- This deviceK143122 Volcano iFR Harvest Software (Offline)Volcano Corporation · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K934139 | Tomtec Echo-View | Tomtec Tomographic Technologies GmbH | 1995 | — |
| −9 | K993398 | Echo View, Easy View, Omni View | Tomtec Imaging Systems GmbH | 1999 | — |
| −8 | 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 | — |
| −7 | K042188 | Volcano Therapeutics, Inc. Volcano Ivus System | Volcano Therapeutics, Inc. | 2004 | — |
| −6 | K051337 | Eagle Eye Gold Ivus Imaging Catheter, Model 85900/859XX; Volcano VH-Ivus… | Volcano Corporation | 2005 | — |
| −5 | K071554 | Volcano S5/S5I Intravascular Imaging and Pressure System | Volcano Corporation | 2008 | 2 |
| −4 | K082229 | S5/S5I Series Intravascular Imaging and Pressure System, Combomap Pressure and… | Volcano Corporation | 2008 | 3 |
| −3 | 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 |
| −1 | K133323 | Volcano Ifr Modality | Volcano Corporation | 2014 | — |
| 0 (this device) | K143122 | Volcano iFR Harvest Software (Offline) | Volcano Corporation | 2015 | — |
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 |
|---|---|---|---|
| * | K133323 | Volcano Ifr ModalitySummary page 4…892.1560 IYO: System, Imaging, Pulsed Echo, Ultrasonic Class II Device PREDICATE DEVICE: Volcano iFR Modality (K133323) DEVICE DESCRIPTION: The Volcano Harvest iFR® Modality is a software tool designed to calculate of… | 2014 |
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 20 years and passes through 4 companies; a new generation was cleared every 2.1 years on median.
- 6 of the 48 ancestors have a recall of any class.
- 5 other devices also cite its predicate K133323.
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. 2015, 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 iFR® Harvest Modality is an offline analysis tool of the currently marketed vasodilator-free pressure measurement module, iFR® Modality of the Volcano s5/s5i/CORE and CORE Mobile systems. It is intended to calculate iFR values from hyperemia-free FFR pressure recordings in a laptop or desktop setting only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K143122 · printed Nov 5, 2026
Cite this page
510(k) Report. “K143122: Volcano iFR Harvest Software (Offline).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K143122
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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