510(k) · Cleared
ClearedFox Plus Pta Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Laboratories, Inc. · LIT Catheter, Angioplasty, Peripheral, Transluminal
Cleared on May 11, 2004 as substantially equivalent to K020854 (Jomed AG, 2002) after a 28-day review. Its family tree reaches back 2 generations to 2000. 5 later devices descend from it.
- Decided
- May 11, 2004
- Review
- 28 days
- Class
- Class II
- Product code
- LIT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K000101 (2000). 4 ancestors in all. 5 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK000101 RX Viatrac 14 Peripheral Dilatation CatheterGuidant Corp. · 2000
- 1 generation backK020854 Modification to Fox Pta CatheterJomed AG · 2002
- This deviceK040954 Fox Plus Pta CatheterAbbott Laboratories, Inc. · 2004
- Descendant · cites it directly · 2 of its ownK051519 Fox SV Pta Catheter (82XXX Series). Fox Plus Pta Catheter (12XXX…Abbott Laboratories (Perclose, Inc.) · 2005
- Descendant · cites it directly · 1 of its ownK080264 Modification to: Fox Plus Pta CatheterAbbott Vascular-Vascular Solutions · 2008
- Descendant · 2 generations on · 1 of its ownK062843 Fox SV Pta CatheterAbbott Laboratories · 2006
- Descendant · 2 generations on · 0 of its ownK080925 Fox Plus Pta CatheterAbbott Vascular, Inc. · 2008
- Descendant · 3 generations on · 0 of its ownK072824 Fox SV Pta CatheterAbbott Laboratories · 2007
Most influential descendants
Showing 5 of 5 · See all- K051519Fox SV Pta Catheter (82XXX Series). Fox Plus Pta Catheter (12XXX Series)Abbott Laboratories (Perclose, Inc.) · 2005 · cites it directly2descendants
- K080264Modification to: Fox Plus Pta CatheterAbbott Vascular-Vascular Solutions · 2008 · cites it directly1descendant
- K062843Fox SV Pta CatheterAbbott Laboratories · 2006 · 2 generations on1descendant
- K080925Fox Plus Pta CatheterAbbott Vascular, Inc. · 2008 · 2 generations on0descendants
- K072824Fox SV Pta CatheterAbbott Laboratories · 2007 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K000101 | RX Viatrac 14 Peripheral Dilatation Catheter | Guidant Corp. | 2000 | — |
| −1 | K020854 | Modification to Fox Pta Catheter | Jomed AG | 2002 | — |
| 0 (this device) | K040954 | Fox Plus Pta Catheter | Abbott Laboratories, Inc. | 2004 | — |
| +1 | K051519 | Fox SV Pta Catheter (82XXX Series). Fox Plus Pta Catheter (12XXX Series) | Abbott Laboratories (Perclose, Inc.) | 2005 | — |
| +1 | K080264 | Modification to: Fox Plus Pta Catheter | Abbott Vascular-Vascular Solutions | 2008 | — |
| +2 | K062843 | Fox SV Pta Catheter | Abbott Laboratories | 2006 | — |
| +2 | K080925 | Fox Plus Pta Catheter | Abbott Vascular, Inc. | 2008 | — |
| +3 | K072824 | Fox SV Pta Catheter | Abbott Laboratories | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 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? (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 |
|---|---|---|---|
| * | K020854 | Modification to Fox Pta CatheterSummary page 1…21 CFR 870.1250 Classification Name: Percutaneous Transluminal Angioplasty Catheter Product Code: LIT Predicate Device: Fox PTA Catheter (K020854) Intended Use: The Fox Plus PTA Catheter is intended for dilatation of lesions in the fe… | 2002 |
What descends from it? (5)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 4 years and passes through 3 companies; a new generation was cleared every 2.2 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K051519 (Abbott Laboratories (Perclose, Inc.), 2005) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K020854.
How does its category compare?
All LIT devicesLIT Catheter, Angioplasty, Peripheral, Transluminal: FDA decisions, review times, recalls and adverse event reports over 20 years.
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/K040954 · printed Nov 3, 2026
Cite this page
510(k) Report. “K040954: 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/K040954
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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