510(k) · Cleared
ClearedReprocessed Visions PV .035 Digital IVUS Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Innovative Health, LLC · OWQ Reprocessed Intravascular Ultrasound Catheter
Cleared on Jan 18, 2019 as substantially equivalent to K153094 (Volcano Corporation, 2015) after a 263-day review. Its family tree reaches back 4 generations to 1999.
- Decided
- Jan 18, 2019
- Review
- 263 days
- Class
- Class II
- Product code
- OWQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K982329 (1999). No later device cites it as a predicate yet.
- Root · 4 generations backK982329 Visions 8.2F PV Ultrasonic Imaging Catheter (Model 88900)Endosonics Corp. · 1999
- 3 generations backK071660 Visions PV 8.2 Intravascular Ultrasound Imaging Catheter, Model 88900Volcano Corporation · 2007
- 2 generations backK121273 Visions PV .035 Ditital Ivus CatheterVolcano Corporation · 2012 · Recalled
- 1 generation backK153094 Visions PV .035 Digital IVUS CatheterVolcano Corporation · 2015 · Recalled
- This deviceK181126 Reprocessed Visions PV .035 Digital IVUS CatheterInnovative Health, LLC · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K982329 | Visions 8.2F PV Ultrasonic Imaging Catheter (Model 88900) | Endosonics Corp. | 1999 | — |
| −3 | K071660 | Visions PV 8.2 Intravascular Ultrasound Imaging Catheter, Model 88900 | Volcano Corporation | 2007 | — |
| −2 | K121273 | Visions PV .035 Ditital Ivus Catheter | Volcano Corporation | 2012 | 3 |
| −1 | K153094 | Visions PV .035 Digital IVUS Catheter | Volcano Corporation | 2015 | 2 |
| 0 (this device) | K181126 | Reprocessed Visions PV .035 Digital IVUS Catheter | Innovative Health, LLC | 2019 | — |
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 OWQ? 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 OWQ device
- #1 K254149 Reprocessed AcuNav CRYSTAL™ Ultrasound…score 13.4 · 7 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 |
|---|---|---|---|
| * | K153094 | Visions PV .035 Digital IVUS CatheterSummary page 5…Product Code: OWQ Predicate Device: 510(k) Number 510(k) Title Manufacturer K153094 Visions PV .035 Digital IVUS Catheter Volcano Corporation Device Description: The Repro… | 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 20 years and passes through 3 companies; a new generation was cleared every 5.0 years on median.
- 2 of the 4 ancestors have a recall of any class.
- 1 other device also cites its predicate K153094.
How does its category compare?
All OWQ devicesOWQ Reprocessed Intravascular Ultrasound Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · OWQ
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OWQ
100in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OWQ
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OWQ
42in 2025
MAUDE reports naming product code OWQ, 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 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 4 |
| 2014 | 0 | — | 1 | 2 |
| 2015 | 0 | — | 0 | 6 |
| 2016 | 2 | — | 0 | 5 |
| 2017 | 2 | — | 0 | 2 |
| 2018 | 1 | — | 0 | 2 |
| 2019 | 3 | 261 | 0 | 9 |
| 2020 | 1 | — | 0 | 29 |
| 2021 | 0 | — | 0 | 38 |
| 2022 | 2 | — | 0 | 24 |
| 2023 | 8 | 78 | 0 | 29 |
| 2024 | 1 | — | 0 | 37 |
| 2025 | 3 | 100 | 2 | 42 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Reprocessed Visions PV .035 catheter is 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 catheter is 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K181126 · printed Nov 5, 2026
Cite this page
510(k) Report. “K181126: Reprocessed Visions PV .035 Digital IVUS Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K181126
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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