510(k) · Cleared
ClearedPasseo-35
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biotronik, Inc. · LIT Catheter, Angioplasty, Peripheral, Transluminal
Cleared on Apr 23, 2013 as substantially equivalent to K082933 (Biotronik, Inc., 2008) after a 90-day review. Its family tree reaches back 5 generations to 2000.
- Decided
- Apr 23, 2013
- Review
- 90 days
- Class
- Class II
- Product code
- LIT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K000101 (2000). 8 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK000101 RX Viatrac 14 Peripheral Dilatation CatheterGuidant Corp. · 2000
- 4 generations backK020854 Modification to Fox Pta CatheterJomed AG · 2002
- 3 generations backK033217 Pheron Pta CatheterBiotronik, Inc. · 2003
- 2 generations backK072765 Passeo 18Biotronik, Inc. · 2007
- 1 generation backK082933 Passeo-35 Pta CatheterBiotronik, Inc. · 2008
- This deviceK130161 Passeo-35Biotronik, Inc. · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K000101 | RX Viatrac 14 Peripheral Dilatation Catheter | Guidant Corp. | 2000 | — |
| −4 | K020854 | Modification to Fox Pta Catheter | Jomed AG | 2002 | — |
| −3 | K033217 | Pheron Pta Catheter | Biotronik, Inc. | 2003 | — |
| −2 | K072765 | Passeo 18 | Biotronik, Inc. | 2007 | — |
| −1 | K082933 | Passeo-35 Pta Catheter | Biotronik, Inc. | 2008 | — |
| 0 (this device) | K130161 | Passeo-35 | Biotronik, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 2 | 0 |
| 2005 | 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 |
|---|---|---|---|
| * | K082933 | Passeo-35 Pta CatheterSummary page 1…rough 510(k) notification and it is its own predicate device for this Special 51 0(k) changes being effected labeling changes: . BIOTRONIK's Passeo-35 PTA Catheter (K082933, cleared November 3, 2008). General Description: The Passeo-35 peripheral transluminal angioplasty (PTA) balloon catheter is indi… | 2008 |
What descends from it?
No later submission names this one as a predicate yet.
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 13 years and passes through 3 companies; a new generation was cleared every 2.2 years on median.
- None of the 8 ancestors has a recall.
- 1 other device also cites its predicate K082933.
How does its category compare?
All LIT devicesLIT Catheter, Angioplasty, Peripheral, Transluminal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 Passeo-35 peripheral dilatation catheter is indicated to dilate stenosis in the renal, iliac, femoral, popliteal and infrapopliteal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130161 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130161: Passeo-35.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130161
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