510(k) · Cleared
ClearedModification to: Fox Plus Pta Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Vascular-Vascular Solutions · LIT Catheter, Angioplasty, Peripheral, Transluminal
Cleared on Mar 26, 2008 as substantially equivalent to K040954 (Abbott Laboratories, Inc., 2004) and 1 other predicate after a 54-day review. Its family tree reaches back 3 generations to 2000. 1 later device descends from it.
- Decided
- Mar 26, 2008
- Review
- 54 days
- Class
- Class II
- Product code
- LIT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K000101 (2000). 6 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK000101 RX Viatrac 14 Peripheral Dilatation CatheterGuidant Corp. · 2000
- 2 generations backK020854 Modification to Fox Pta CatheterJomed AG · 2002
- 1 generation backK040954 Fox Plus Pta CatheterAbbott Laboratories, Inc. · 2004
- This deviceK080264 Modification to: Fox Plus Pta CatheterAbbott Vascular-Vascular Solutions · 2008
- Descendant · cites it directly · 0 of its ownK080925 Fox Plus Pta CatheterAbbott Vascular, Inc. · 2008
Most influential descendants
Showing 1 of 1 · See all- K080925Fox Plus Pta CatheterAbbott Vascular, Inc. · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K000101 | RX Viatrac 14 Peripheral Dilatation Catheter | Guidant Corp. | 2000 | — |
| −2 | K020854 | Modification to Fox Pta Catheter | Jomed AG | 2002 | — |
| −1 | K040954 | Fox Plus Pta Catheter | Abbott Laboratories, Inc. | 2004 | — |
| 0 (this device) | K080264 | Modification to: Fox Plus Pta Catheter | Abbott Vascular-Vascular Solutions | 2008 | — |
| +1 | K080925 | Fox Plus Pta Catheter | Abbott Vascular, Inc. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 2 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 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 LIT? 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 LIT device
- #1 K241040 Amethyst HP PTA OTW 0.035 Catheterscore 13.9 · 9 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 |
|---|---|---|---|
| * | K040954 | Fox Plus Pta CatheterSummary page 1…Device Product Code: LIT Predicate Devices The subject device is substantially equivalent to the Fox Plus PTA Catheter predicate device (K040954, cleared on May 11, 2004) and to the SailorTM Plus PTA Balloon Dilatation Catheter predicate device (K042538, cleared on… | 2004 |
| * | K042538 | Sailor Plus Percutaneous Transluminal Angioplasty (Pta) Catheter, Model SaexxxxxxxxxSummary page 1…t to the Fox Plus PTA Catheter predicate device (K040954, cleared on May 11, 2004) and to the SailorTM Plus PTA Balloon Dilatation Catheter predicate device (K042538, cleared on November 8, 2004). Device Description The Fox Plus PTA Catheter is a standard over-the-wire PTA cathete… | 2004 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K080925 | Fox Plus Pta Catheter | 2008 | 0 |
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 8 years and passes through 4 companies; a new generation was cleared every 2.2 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K080925 (Abbott Vascular, Inc., 2008) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K040954.
How does its category compare?
All LIT devicesLIT Catheter, Angioplasty, Peripheral, Transluminal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · LIT
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LIT
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LIT
1in 2025
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · LIT
2,073in 2025
MAUDE reports naming product code LIT, 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 | 6 | 64 | 0 | 577 |
| 2008 | 8 | 53 | 0 | 513 |
| 2009 | 7 | 29 | 2 | 623 |
| 2010 | 13 | 78 | 1 | 809 |
| 2011 | 10 | 82 | 0 | 857 |
| 2012 | 19 | 29 | 0 | 1,277 |
| 2013 | 14 | 79 | 2 (2) | 1,242 |
| 2014 | 12 | 90 | 3 | 1,178 |
| 2015 | 19 | 112 | 0 | 1,279 |
| 2016 | 11 | 116 | 1 | 1,529 |
| 2017 | 9 | 57 | 0 | 2,081 |
| 2018 | 6 | 118 | 2 | 2,188 |
| 2019 | 4 | 40 | 3 | 2,405 |
| 2020 | 9 | 125 | 0 | 2,443 |
| 2021 | 4 | 61 | 1 | 2,492 |
| 2022 | 8 | 122 | 0 | 2,155 |
| 2023 | 6 | 167 | 0 | 1,807 |
| 2024 | 6 | 43 | 2 | 1,913 |
| 2025 | 3 | 90 | 1 | 2,073 |
| 2026 | 4 | 205 | 0 | — |
What is it indicated for?
The Fox Plus PTA Catheter is intended for dilatation of lesions in the femoral,
renal, iliac, popliteal, peroneal and profunda arteries and native or synthetic
arteriovenous dialysis fistulae.
This catheter is not intended for the expansion or delivery of stents.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080264 · printed Nov 3, 2026
Cite this page
510(k) Report. “K080264: Modification to: Fox Plus Pta Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K080264
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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