510(k) · Cleared
ClearedVisions 8.2F PV Ultrasonic Imaging Catheter (Model 88900)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Endosonics Corp. · ITX Transducer, Ultrasonic, Diagnostic
Cleared on Jan 14, 1999 after a 196-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below). 5 later devices descend from it.
- Decided
- Jan 14, 1999
- Review
- 196 days
- Class
- Class II
- Product code
- ITX
- Recalls
- None
- Predicates
- 1
5 later devices descend from it, 1 citing it directly.
- This deviceK982329 Visions 8.2F PV Ultrasonic Imaging Catheter (Model 88900)Endosonics Corp. · 1999
- Descendant · cites it directly · 4 of its ownK071660 Visions PV 8.2 Intravascular Ultrasound Imaging Catheter, Model 88900Volcano Corporation · 2007
- Descendant · 2 generations on · 3 of its ownK121273 Visions PV .035 Ditital Ivus CatheterVolcano Corporation · 2012 · Recalled
- Descendant · 3 generations on · 2 of its ownK153094 Visions PV .035 Digital IVUS CatheterVolcano Corporation · 2015 · Recalled
- Descendant · 4 generations on · 0 of its ownK230584 Vein360 Reprocessed Visions PV.035 Digital IVUS CatheterVein 360, LLC · 2023
- Descendant · 4 generations on · 0 of its ownK181126 Reprocessed Visions PV .035 Digital IVUS CatheterInnovative Health, LLC · 2019
Most influential descendants
Showing 5 of 5 · See all- K071660Visions PV 8.2 Intravascular Ultrasound Imaging Catheter, Model 88900Volcano Corporation · 2007 · cites it directly4descendants
- K121273Visions PV .035 Ditital Ivus CatheterVolcano Corporation · 2012 · 2 generations on3descendants
- K153094Visions PV .035 Digital IVUS CatheterVolcano Corporation · 2015 · 3 generations on2descendants
- K230584Vein360 Reprocessed Visions PV.035 Digital IVUS CatheterVein 360, LLC · 2023 · 4 generations on0descendants
- K181126Reprocessed Visions PV .035 Digital IVUS CatheterInnovative Health, LLC · 2019 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | 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 | — |
| +2 | K121273 | Visions PV .035 Ditital Ivus Catheter | Volcano Corporation | 2012 | 3 |
| +3 | K153094 | Visions PV .035 Digital IVUS Catheter | Volcano Corporation | 2015 | 2 |
| +4 | K230584 | Vein360 Reprocessed Visions PV.035 Digital IVUS Catheter | Vein 360, LLC | 2023 | — |
| +4 | K181126 | Reprocessed Visions PV .035 Digital IVUS Catheter | Innovative Health, LLC | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2012 | 1 | 0 |
| 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 ITX? 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 ITX device
- #1 K260114 Align® Cover and Pad Guidance Toolscore 13.6 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (7)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K955379 | FDA’s K955379 is Ibc Gas Cell Components (1/2, 3/8, 1/4) Our OCR of the scanned summary read K955379, FDA’s number for Ibc Gas Cell Components (1/2, 3/8, 1/4) (International Biophysics Corp.). Its FDA name has none of the distinctive words the summary uses for the device it names, “EndoSonics Visions 3.5F model 84700 Intravascular Imaging Catheter”. Kept off the family tree. Summary page 1EndoSonics Visions 8.2F PV Modets 88900 Submitted By: Summary Preparation: Device: Common or Usual Name: Predicate Devices: (955379 510(k) Premarket Notification June 30, 1998 510(k) Summary EndoSonics Corporation 2870 Kilgore Road Rancho Cordova, CA 95670… | 1996 |
| * | — | EndoSonics Cathscanner Model 302 Intravascular Imaging Catheter Named without a submission number | |
| * | — | Oracle (Cathscanner IIT) Imaging System Named without a submission number | |
| * | — | Cook Small Vessel Balloon Angioplasty catheter Named without a submission number | |
| * | — | ATL Ultramark 8 imaging system Named without a submission number | |
| * | — | Millar Mikro Tip Doppler catheter Named without a submission number | |
| * | — | CVIS Insight imaging system and catheters Named without a submission number |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K071660 | Visions PV 8.2 Intravascular Ultrasound Imaging Catheter, Model 88900 | 2007 | 4 |
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?
- Of its descendants, K071660 (Volcano Corporation, 2007) has gone furthest, with 4 descendants of its own.
How does its category compare?
All ITX devicesITX Transducer, Ultrasonic, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · ITX
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ITX
126in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ITX
2in 2025
Class I (10 since 2007) Class II/III not classified
Adverse event reports per year · ITX
571in 2025
MAUDE reports naming product code ITX, 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 | 10 | 26 | 0 | 16 |
| 2008 | 12 | 73 | 4 | 39 |
| 2009 | 17 | 28 | 4 | 23 |
| 2010 | 10 | 42 | 4 | 30 |
| 2011 | 10 | 16 | 1 | 34 |
| 2012 | 7 | 25 | 1 | 29 |
| 2013 | 3 | 105 | 0 | 38 |
| 2014 | 4 | 41 | 1 | 43 |
| 2015 | 1 | — | 5 | 183 |
| 2016 | 4 | 151 | 0 | 269 |
| 2017 | 6 | 110 | 1 | 412 |
| 2018 | 2 | — | 15 | 130 |
| 2019 | 1 | — | 0 | 119 |
| 2020 | 3 | 120 | 3 | 116 |
| 2021 | 3 | 139 | 10 (10) | 146 |
| 2022 | 2 | — | 6 | 87 |
| 2023 | 6 | 213 | 1 | 138 |
| 2024 | 3 | 81 | 1 | 988 |
| 2025 | 4 | 126 | 2 | 571 |
| 2026 | 6 | 158 | 0 | — |
What is it indicated for?
The Visions 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 ultrasound imaging catheter is designed for use as an adjunct to conventional angiographic procedures to provide:
(1) An image of the vessel lumen and wall structures.
(2) 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/K982329 · printed Nov 4, 2026
Cite this page
510(k) Report. “K982329: Visions 8.2F PV Ultrasonic Imaging Catheter (Model 88900).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K982329
Report an extraction error
Are you the manufacturer?
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