510(k) · Cleared
ClearedModification to Fox Pta Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Jomed AG · LIT Catheter, Angioplasty, Peripheral, Transluminal
Cleared on Apr 11, 2002 as substantially equivalent to K010838 (Jomed AG, 2001) and 2 other predicates after a 27-day review. Its family tree reaches back 1 generation to 2000. 16 later devices descend from it.
- Decided
- Apr 11, 2002
- Review
- 27 days
- Class
- Class II
- Product code
- LIT
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K000101 (2000). 3 ancestors in all. 16 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK000101 RX Viatrac 14 Peripheral Dilatation CatheterGuidant Corp. · 2000
- This deviceK020854 Modification to Fox Pta CatheterJomed AG · 2002
- Descendant · cites it directly · 8 of its ownK033217 Pheron Pta CatheterBiotronik, Inc. · 2003
- Descendant · 2 generations on · 7 of its ownK072765 Passeo 18Biotronik, Inc. · 2007
- Descendant · 2 generations on · 5 of its ownK082933 Passeo-35 Pta CatheterBiotronik, Inc. · 2008
- Descendant · cites it directly · 5 of its ownK040954 Fox Plus Pta CatheterAbbott Laboratories, Inc. · 2004
- Descendant · 3 generations on · 3 of its ownK142379 Passeo-35 PTA CatheterBiotronik, Inc. · 2014
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K033217Pheron Pta CatheterBiotronik, Inc. · 2003 · cites it directly8descendants
- K072765Passeo 18Biotronik, Inc. · 2007 · 2 generations on7descendants
- K082933Passeo-35 Pta CatheterBiotronik, Inc. · 2008 · 2 generations on5descendants
- K040954Fox Plus Pta CatheterAbbott Laboratories, Inc. · 2004 · cites it directly5descendants
- K142379Passeo-35 PTA CatheterBiotronik, Inc. · 2014 · 3 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K000101 | RX Viatrac 14 Peripheral Dilatation Catheter | Guidant Corp. | 2000 | — |
| 0 (this device) | K020854 | Modification to Fox Pta Catheter | Jomed AG | 2002 | — |
| +1 | K033217 | Pheron Pta Catheter | Biotronik, Inc. | 2003 | — |
| +2 | K072765 | Passeo 18 | Biotronik, Inc. | 2007 | — |
| +2 | K082933 | Passeo-35 Pta Catheter | Biotronik, Inc. | 2008 | — |
| +1 | K040954 | Fox Plus Pta Catheter | Abbott Laboratories, Inc. | 2004 | — |
| +3 | K142379 | Passeo-35 PTA Catheter | Biotronik, Inc. | 2014 | — |
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 |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
| 2008 | 3 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2023 | 1 | 0 |
| 2025 | 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? (3)
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.
What descends from it? (16)
See all 163 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?
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 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.
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/K020854 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020854: Modification to Fox Pta Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020854
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