510(k) · Cleared
Recalled · Class II · 2022Visions PV .035 Ditital 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 10, 2012 as substantially equivalent to K071660 (Volcano Corporation, 2007) after a 136-day review. Its family tree reaches back 2 generations to 1999. 3 later devices descend from it. It has been recalled 3 times.
- Decided
- Sep 10, 2012
- Review
- 136 days
- Class
- Class II
- Product code
- OBJ
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 2 generations to K982329 (1999). 3 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK982329 Visions 8.2F PV Ultrasonic Imaging Catheter (Model 88900)Endosonics Corp. · 1999
- 1 generation backK071660 Visions PV 8.2 Intravascular Ultrasound Imaging Catheter, Model 88900Volcano Corporation · 2007
- This deviceK121273 Visions PV .035 Ditital Ivus CatheterVolcano Corporation · 2012
- Descendant · cites it directly · 2 of its ownK153094 Visions PV .035 Digital IVUS CatheterVolcano Corporation · 2015 · Recalled
- Descendant · 2 generations on · 0 of its ownK230584 Vein360 Reprocessed Visions PV.035 Digital IVUS CatheterVein 360, LLC · 2023
- Descendant · 2 generations on · 0 of its ownK181126 Reprocessed Visions PV .035 Digital IVUS CatheterInnovative Health, LLC · 2019
Most influential descendants
Showing 3 of 3 · See all- K153094Visions PV .035 Digital IVUS CatheterVolcano Corporation · 2015 · cites it directly2descendants
- K230584Vein360 Reprocessed Visions PV.035 Digital IVUS CatheterVein 360, LLC · 2023 · 2 generations on0descendants
- K181126Reprocessed Visions PV .035 Digital IVUS CatheterInnovative Health, LLC · 2019 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K982329 | Visions 8.2F PV Ultrasonic Imaging Catheter (Model 88900) | Endosonics Corp. | 1999 | — |
| −1 | K071660 | Visions PV 8.2 Intravascular Ultrasound Imaging Catheter, Model 88900 | Volcano Corporation | 2007 | — |
| 0 (this device) | K121273 | Visions PV .035 Ditital Ivus Catheter | Volcano Corporation | 2012 | — |
| +1 | K153094 | Visions PV .035 Digital IVUS Catheter | Volcano Corporation | 2015 | 2 |
| +2 | K230584 | Vein360 Reprocessed Visions PV.035 Digital IVUS Catheter | Vein 360, LLC | 2023 | — |
| +2 | K181126 | Reprocessed Visions PV .035 Digital IVUS Catheter | Innovative Health, LLC | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2019 | 1 | 0 |
| 2023 | 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 |
|---|---|---|---|
| * | K071660 | Visions PV 8.2 Intravascular Ultrasound Imaging Catheter, Model 88900Summary page 1…ic Imaging System Predicate Devices: Volcano Visions PV 8.2 PV IVUS Imaging Catheter, 5 10(k) Number K07 1660 Classification Code: OBJ, ITX Device Description The Visions PV .035 Catheter is an over-the-wire intravascular imaging catheter… | 2007 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K153094 | Visions PV .035 Digital IVUS Catheter | 2015 | 2 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 13, 2022 | Class III | Z-1301-2022 | Process control | Digital IVUS catheter instructions for use ( IFU) do not contain contrainidications |
| Oct 17, 2018 | Class II | Z-0726-2019 | Under Investigation by firm | Visions PV .035 Intravascular Ultrasound (IVUS) Catheters (catalog number 88901 adnd81234) due to the potential inability to pass the guidewire through the y-port of the catheter. |
| Jun 4, 2015 | Class II | Z-1844-2015 | Labeling mix-ups | During a relabeling procedure at the manufacturing facility, the products were labeled with a shelf life in accordance with the date of the relabeling and not in accordance with the original shelf life date at the time of manufacture |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 years and passes through 2 companies; a new generation was cleared every 8.6 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K153094 (Volcano Corporation, 2015) has gone furthest, with 2 descendants of its own.
How does its category compare?
All OBJ devicesOBJ Catheter, Ultrasound, Intravascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 .035 catheters are designed for use in the evaluation of vascular morphology in blood vessels of the peripheral vasculature by providing a cross-sectional image of such vessels.
The Visions PV .035 ultrasound imaging catheters are designed for use as an adjunct to conventional angiographic procedures to provide an image of the vessel lumen and wall structures and dimensional measurements from the image.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121273 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121273: Visions PV .035 Ditital 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/K121273
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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