510(k) · Cleared
Recalled · Class II · 2025Volcano Visions PV .018 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 Sep 4, 2015 as substantially equivalent to K944004 (Endosonics Corp., 1995) after a 196-day review. Its family tree reaches back 1 generation to 1995. 5 later devices descend from it. It has been recalled once.
- Decided
- Sep 4, 2015
- Review
- 196 days
- Class
- Class II
- Product code
- OBJ
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K944004 (1995). 5 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK944004 Visions 2.9F Ultrasonic Imaging Catheter (Model 84300)Endosonics Corp. · 1995
- This deviceK150442 Volcano Visions PV .018 Digital IVUS CatheterVolcano Corporation · 2015
- Descendant · cites it directly · 1 of its ownK200410 Reconnaissance PV .018 OTW Digital IVUS CatheterPhilips Image Guided Therapy Corporation · 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 ownK250592 NES Reprocessed Visions PV .018 Digital IVUS Catheter (R-86700)Northeast Scientific, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK233948 Provisio™ SLT IVUS™ SystemProvisio Medical, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK230928 Vein360 Reprocessed Visions PV.018 Digital IVUS CatheterVein 360, LLC · 2023
Most influential descendants
Showing 5 of 5 · See all- K200410Reconnaissance PV .018 OTW Digital IVUS CatheterPhilips Image Guided Therapy Corporation · 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
- K250592NES Reprocessed Visions PV .018 Digital IVUS Catheter (R-86700)Northeast Scientific, Inc. · 2025 · cites it directly0descendants
- K233948Provisio™ SLT IVUS™ SystemProvisio Medical, Inc. · 2024 · 2 generations on0descendants
- K230928Vein360 Reprocessed Visions PV.018 Digital IVUS CatheterVein 360, LLC · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K944004 | Visions 2.9F Ultrasonic Imaging Catheter (Model 84300) | Endosonics Corp. | 1995 | — |
| 0 (this device) | K150442 | Volcano Visions PV .018 Digital IVUS Catheter | Volcano Corporation | 2015 | — |
| +1 | K200410 | Reconnaissance PV .018 OTW Digital IVUS Catheter | Philips Image Guided Therapy Corporation | 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 | K250592 | NES Reprocessed Visions PV .018 Digital IVUS Catheter (R-86700) | Northeast Scientific, Inc. | 2025 | — |
| +2 | K233948 | Provisio™ SLT IVUS™ System | Provisio Medical, Inc. | 2024 | — |
| +1 | K230928 | Vein360 Reprocessed Visions PV.018 Digital IVUS Catheter | Vein 360, LLC | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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 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 |
|---|---|---|---|
| * | K944004 | Visions 2.9F Ultrasonic Imaging Catheter (Model 84300)Summary page 4…ITX Ultrasound Transducer PANEL: Cardiovascular PREDICATE DEVICE: Visions F/X Model 82700 (K944004) DEVICE DESCRIPTION: The Visions® PV .018 Digital IVUS Catheter incorporates a cylindrical ultrasound transducer array located… | 1995 |
What descends from it? (5)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K200410 | Reconnaissance PV .018 OTW Digital IVUS Catheter | 2020 | 1 |
| K253399 | Visions® PV .014P RX Digital IVUS Catheter ; Visions® PV .018 Digital IVUS Catheter | 2025 | 0 |
| K250592 | NES Reprocessed Visions PV .018 Digital IVUS Catheter (R-86700) | 2025 | 0 |
| K230928 | Vein360 Reprocessed Visions PV.018 Digital IVUS Catheter | 2023 | 0 |
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?
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 .018 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 cerebral vessels.
The Visions® PV .018 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/K150442 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150442: Volcano Visions PV .018 Digital IVUS Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150442
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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