510(k) · Cleared
ClearedVisions® PV .014P RX Digital IVUS Catheter ; 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 (Dba Philips Image Guided Therapy Device · OBJ Catheter, Ultrasound, Intravascular
Cleared on Oct 28, 2025 as substantially equivalent to K152829 (Volcano Corporation, 2015) and 1 other predicate after a 28-day review. Its family tree reaches back 10 generations to 1995.
- Decided
- Oct 28, 2025
- Review
- 28 days
- Class
- Class II
- Product code
- OBJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to K934139 (1995). 15 ancestors in all. 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 backK120697 Eagle Eye Platinum ST CatheterVolcano Corporation · 2012
- 2 generations backK143701 Eagle Eye Platinum Catheter, Eagle Eye Platinum Short Tip Catheter…Volcano Corporation · 2015
- 1 generation backK152829 Visions PV.014P RX Digital IVUS CatheterVolcano Corporation · 2015 · Recalled
- This deviceK253399 Visions® PV .014P RX Digital IVUS Catheter ; Visions® PV .018…Volcano Corporation (Dba Philips Image Guided Therapy Device · 2025
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 backK073473 Eagle Eye Gold Ivus Imaging Catheter, Model 85900, Avabar F/X Ivus…Volcano Corporation · 2008
- 4 generations backK092596 Eagle Eye Platinum Digital Ivus CatheterVolcano Corporation · 2009
- 3 generations backK120697 Eagle Eye Platinum ST CatheterVolcano Corporation · 2012
- 2 generations backK143701 Eagle Eye Platinum Catheter, Eagle Eye Platinum Short Tip Catheter…Volcano Corporation · 2015
- 1 generation backK152829 Visions PV.014P RX Digital IVUS CatheterVolcano Corporation · 2015 · Recalled
- This deviceK253399 Visions® PV .014P RX Digital IVUS Catheter ; Visions® PV .018…Volcano Corporation (Dba Philips Image Guided Therapy Device · 2025
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 | K073473 | Eagle Eye Gold Ivus Imaging Catheter, Model 85900, Avabar F/X Ivus Imaging… | Volcano Corporation | 2008 | — |
| −4 | K092596 | Eagle Eye Platinum Digital Ivus Catheter | Volcano Corporation | 2009 | — |
| −3 | K120697 | Eagle Eye Platinum ST Catheter | Volcano Corporation | 2012 | — |
| −2 | K143701 | Eagle Eye Platinum Catheter, Eagle Eye Platinum Short Tip Catheter, Visions PV… | Volcano Corporation | 2015 | — |
| −1 | K152829 | Visions PV.014P RX Digital IVUS Catheter | Volcano Corporation | 2015 | 1 |
| 0 (this device) | K253399 | Visions® PV .014P RX Digital IVUS Catheter ; Visions® PV .018 Digital IVUS… | Volcano Corporation (Dba Philips Image Guided Therapy Device | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 2000 | 2 | 0 |
| 2003 | 1 | 0 |
| 2015 | 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? (2)
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 |
|---|---|---|---|
| * | K152829 | Visions PV.014P RX Digital IVUS CatheterSummary page 6…21 CFR 892.1570 Diagnostic Ultrasound Transducer Product Codes OBJ, ITX Panel: Cardiovascular 510(k) Number K152829 Clearance Date 11/19/2015 Predicate Device 2: Trade Name Visions PV .018 Digital IVUS Cathe… | 2015 |
| * | K150442 | Volcano Visions PV .018 Digital IVUS CatheterSummary page 6…21 CFR 892.1570 Diagnostic Ultrasound Transducer Product Codes OBJ, ITX Panel: Cardiovascular 510(k) Number K150442 Clearance Date 09/04/2015 Device Description: The Visions® PV .014P RX Digital IVUS Catheter and the Visions®… | 2015 |
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 30 years and passes through 5 companies; a new generation was cleared every 2.4 years on median.
- 2 of the 15 ancestors have a recall of any class.
- 2 other devices also cite its predicate K152829.
How does its category compare?
All OBJ devicesOBJ Catheter, Ultrasound, Intravascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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?
Visions® PV.014P RX Digital IVUS Catheter: 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…
Read the full statement (161 words)
Visions® PV.014P RX Digital IVUS Catheter:
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.
Visions® PV .018 Digital IVUS Catheter:
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/K253399 · printed Nov 6, 2026
Cite this page
510(k) Report. “K253399: Visions® PV .014P RX Digital IVUS Catheter ; 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/K253399
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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