510(k) · Cleared
Recalled · Class II · 2025Visions PV.014P RX Digital IVUS Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Volcano Corporation · OBJ Catheter, Ultrasound, Intravascular
Cleared on Nov 19, 2015 as substantially equivalent to K143701 (Volcano Corporation, 2015) after a 51-day review. Its family tree reaches back 9 generations to 1995. 4 later devices descend from it. It has been recalled once.
- Decided
- Nov 19, 2015
- Review
- 51 days
- Class
- Class II
- Product code
- OBJ
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 9 generations to K934139 (1995). 12 ancestors in all. 4 later devices descend from it, 3 citing it directly.
- Root · 9 generations backK934139 Tomtec Echo-ViewTomtec Tomographic Technologies GmbH · 1995
- 5 generations between
- 3 generations backK092596 Eagle Eye Platinum Digital Ivus CatheterVolcano Corporation · 2009
- 2 generations backK120697 Eagle Eye Platinum ST CatheterVolcano Corporation · 2012
- 1 generation backK143701 Eagle Eye Platinum Catheter, Eagle Eye Platinum Short Tip Catheter…Volcano Corporation · 2015
- This deviceK152829 Visions PV.014P RX Digital IVUS CatheterVolcano Corporation · 2015
- Descendant · cites it directly · 1 of its ownK200195 NES Reprocessed Visions PV .014P RX Digital IVUS CatheterNortheast Scientific, Inc. · 2020
- Descendant · cites it directly · 0 of its ownK253399 Visions® PV .014P RX Digital IVUS Catheter ; Visions® PV .018…Volcano Corporation (Dba Philips Image Guided Therapy Device · 2025
- Descendant · cites it directly · 0 of its ownK232584 Vein360 Reprocessed Visions PV.014P Rx Digital IVUS Catheter…Vein 360, LLC · 2023
- Descendant · 2 generations on · 0 of its ownK223026 NES Reprocessed Eagle Eye Platinum RX Digital IVUS CatheterNortheast Scientific, Inc. · 2023
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 backK073473 Eagle Eye Gold Ivus Imaging Catheter, Model 85900, Avabar F/X Ivus…Volcano Corporation · 2008
- 3 generations backK092596 Eagle Eye Platinum Digital Ivus CatheterVolcano Corporation · 2009
- 2 generations backK120697 Eagle Eye Platinum ST CatheterVolcano Corporation · 2012
- 1 generation backK143701 Eagle Eye Platinum Catheter, Eagle Eye Platinum Short Tip Catheter…Volcano Corporation · 2015
- This deviceK152829 Visions PV.014P RX Digital IVUS CatheterVolcano Corporation · 2015
Most influential descendants
Showing 4 of 4 · See all- K200195NES Reprocessed Visions PV .014P RX Digital IVUS CatheterNortheast Scientific, Inc. · 2020 · cites it directly1descendant
- K253399Visions® PV .014P RX Digital IVUS Catheter ; Visions® PV .018 Digital IVUS CatheterVolcano Corporation (Dba Philips Image Guided Therapy Device · 2025 · cites it directly0descendants
- K232584Vein360 Reprocessed Visions PV.014P Rx Digital IVUS Catheter, Vein360 Reprocessed Eagle…Vein 360, LLC · 2023 · cites it directly0descendants
- K223026NES Reprocessed Eagle Eye Platinum RX Digital IVUS CatheterNortheast Scientific, Inc. · 2023 · 2 generations on0descendants
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 | K073473 | Eagle Eye Gold Ivus Imaging Catheter, Model 85900, Avabar F/X Ivus Imaging… | Volcano Corporation | 2008 | — |
| −3 | K092596 | Eagle Eye Platinum Digital Ivus Catheter | Volcano Corporation | 2009 | — |
| −2 | K120697 | Eagle Eye Platinum ST Catheter | Volcano Corporation | 2012 | — |
| −1 | K143701 | Eagle Eye Platinum Catheter, Eagle Eye Platinum Short Tip Catheter, Visions PV… | Volcano Corporation | 2015 | — |
| 0 (this device) | K152829 | Visions PV.014P RX Digital IVUS Catheter | Volcano Corporation | 2015 | — |
| +1 | K200195 | NES Reprocessed Visions PV .014P RX Digital IVUS Catheter | Northeast Scientific, Inc. | 2020 | — |
| +1 | K253399 | Visions® PV .014P RX Digital IVUS Catheter ; Visions® PV .018 Digital IVUS… | Volcano Corporation (Dba Philips Image Guided Therapy Device | 2025 | — |
| +1 | K232584 | Vein360 Reprocessed Visions PV.014P Rx Digital IVUS Catheter, Vein360… | Vein 360, LLC | 2023 | — |
| +2 | K223026 | NES Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter | Northeast Scientific, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 2 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2023 | 2 | 0 |
| 2025 | 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 OBJ? 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 OBJ device
- #1 K242893 VERAFEYE System VERAFEYE Imaging Catheter &…score 23.8 · 30 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 |
|---|---|---|---|
| * | K143701 | Eagle Eye Platinum Catheter, Eagle Eye Platinum Short Tip Catheter, Visions PV .014…Summary page 4…ar Catheter II OBJ 21 CFR 892.1570 Diagnostic Ultrasound Transducer II ITX PREDICATE DEVICE: Trade Name: K143701-Eagle Eye Platinum Catheter (EEP), Eagle Eye Platinum Short Tip (EEP-ST), Visions ® PV.014… | 2015 |
What descends from it? (4)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 13, 2025 | Class II | Z-2221-2025 | — | Reports of IVUS catheter and guide wire entanglement during radial-to-peripheral procedures, due to catheter use without appropriate sheath and/or guide catheter, which may require further intervention, such as surgical removal; Firm is… |
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 2.3 years on median.
- None of the 12 ancestors has a recall.
- Of its descendants, K200195 (Northeast Scientific, Inc., 2020) has gone furthest, with 1 descendant of its own.
- 4 other devices also cite its predicate K143701.
How does its category compare?
All OBJ devicesOBJ Catheter, Ultrasound, Intravascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · OBJ
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OBJ
35in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OBJ
2in 2020
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · OBJ
791in 2025
MAUDE reports naming product code OBJ, 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 | 3 | 74 | 0 | 0 |
| 2008 | 6 | 100 | 0 | 6 |
| 2009 | 3 | 108 | 0 | 22 |
| 2010 | 1 | — | 0 | 39 |
| 2011 | 4 | 109 | 0 | 47 |
| 2012 | 3 | 136 | 0 | 53 |
| 2013 | 4 | 96 | 0 | 328 |
| 2014 | 3 | 30 | 0 | 609 |
| 2015 | 4 | 131 | 2 | 401 |
| 2016 | 4 | 94 | 0 | 515 |
| 2017 | 6 | 45 | 2 | 524 |
| 2018 | 2 | — | 2 | 542 |
| 2019 | 1 | — | 0 | 237 |
| 2020 | 4 | 135 | 2 | 288 |
| 2021 | 3 | 29 | 0 | 353 |
| 2022 | 3 | 63 | 0 | 473 |
| 2023 | 3 | 63 | 0 | 697 |
| 2024 | 3 | 131 | 0 | 1,154 |
| 2025 | 7 | 35 | 0 | 791 |
| 2026 | 4 | 81 | 1 (1) | — |
What is it indicated for?
The Visions® PV.014P RX Digital IVUS Catheter is designed for use in the evaluation of vascular morphology in blood vessels of the coronary and peripheral vasculature by providing a cross-sectional image of such vessels. This device is not currently indicated for use in the cerebral vessels.
The Visions® PV.014P RX Digital IVUS Catheter is designed for use as an adjunct to conventional angiographic procedures to provide an image of the vessel lumen and wall structures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K152829 · printed Nov 3, 2026
Cite this page
510(k) Report. “K152829: Visions PV.014P RX Digital IVUS Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K152829
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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