510(k) · Cleared
ClearedFox SV Pta Catheter (82XXX Series). Fox Plus Pta Catheter (12XXX Series)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Laboratories (Perclose, Inc.) · LIT Catheter, Angioplasty, Peripheral, Transluminal
Cleared on Jun 21, 2005 as substantially equivalent to K040954 (Abbott Laboratories, Inc., 2004) after a 13-day review. Its family tree reaches back 3 generations to 2000. 2 later devices descend from it.
- Decided
- Jun 21, 2005
- Review
- 13 days
- Class
- Class II
- Product code
- LIT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K000101 (2000). 5 ancestors in all. 2 later devices descend 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 deviceK051519 Fox SV Pta Catheter (82XXX Series). Fox Plus Pta Catheter (12XXX…Abbott Laboratories (Perclose, Inc.) · 2005
- Descendant · cites it directly · 1 of its ownK062843 Fox SV Pta CatheterAbbott Laboratories · 2006
- Descendant · 2 generations on · 0 of its ownK072824 Fox SV Pta CatheterAbbott Laboratories · 2007
Most influential descendants
Showing 2 of 2 · See allView 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) | K051519 | Fox SV Pta Catheter (82XXX Series). Fox Plus Pta Catheter (12XXX Series) | Abbott Laboratories (Perclose, Inc.) | 2005 | — |
| +1 | K062843 | Fox SV Pta Catheter | Abbott Laboratories | 2006 | — |
| +2 | 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 |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 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? (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 |
|---|---|---|---|
| * | K040954 | Fox Plus Pta CatheterSummary page 1…1250 Classification Name: Percutaneous Transluminal Angioplasty Catheter Product Code: LIT Predicate Device: Fox Plus PTA Catheter (K040954) Intended Use: The Fox SV PTA Catheter is intended for dilatation of lesions in the… | 2004 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K062843 | Fox SV Pta Catheter | 2006 | 1 |
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 5 years and passes through 4 companies; a new generation was cleared every 2.1 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K062843 (Abbott Laboratories, 2006) has gone furthest, with 1 descendant 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.
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 SV 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/K051519 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051519: Fox SV Pta Catheter (82XXX Series). Fox Plus Pta Catheter (12XXX Series).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051519
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