510(k) · Cleared
ClearedPasseo-18 Peripheral Dilation Catheter
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 Oct 8, 2015 as substantially equivalent to K072765 (Biotronik, Inc., 2007) after a 101-day review. Its family tree reaches back 4 generations to 2000. 1 later device descends from it.
- Decided
- Oct 8, 2015
- Review
- 101 days
- Class
- Class II
- Product code
- LIT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K000101 (2000). 7 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK000101 RX Viatrac 14 Peripheral Dilatation CatheterGuidant Corp. · 2000
- 3 generations backK020854 Modification to Fox Pta CatheterJomed AG · 2002
- 2 generations backK033217 Pheron Pta CatheterBiotronik, Inc. · 2003
- 1 generation backK072765 Passeo 18Biotronik, Inc. · 2007
- This deviceK151744 Passeo-18 Peripheral Dilation CatheterBiotronik, Inc. · 2015
- Descendant · cites it directly · 0 of its ownK250706 Passeo-35 Xeo Peripheral Dilatation Catheter; Passeo-18 Peripheral…Biotronik, Inc. · 2025
Most influential descendants
Showing 1 of 1 · See all- K250706Passeo-35 Xeo Peripheral Dilatation Catheter; Passeo-18 Peripheral Dilatation Catheters…Biotronik, Inc. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K000101 | RX Viatrac 14 Peripheral Dilatation Catheter | Guidant Corp. | 2000 | — |
| −3 | K020854 | Modification to Fox Pta Catheter | Jomed AG | 2002 | — |
| −2 | K033217 | Pheron Pta Catheter | Biotronik, Inc. | 2003 | — |
| −1 | K072765 | Passeo 18 | Biotronik, Inc. | 2007 | — |
| 0 (this device) | K151744 | Passeo-18 Peripheral Dilation Catheter | Biotronik, Inc. | 2015 | — |
| +1 | K250706 | Passeo-35 Xeo Peripheral Dilatation Catheter; Passeo-18 Peripheral Dilatation… | Biotronik, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 2 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K072765 | Passeo 18Summary page 4…LIT Predicate Device: 510(k) # Device Name Manufacturer Date of Clearance Predicate: K072765 Passeo-18 BIOTRONIK 12-Dec-2007 General Description: The Passeo-18 peripheral dila… | 2007 |
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 |
|---|---|---|---|
| K250706 | Passeo-35 Xeo Peripheral Dilatation Catheter; Passeo-18 Peripheral Dilatation Catheters… | 2025 | 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 15 years and passes through 3 companies; a new generation was cleared every 4.1 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K250706 (Biotronik, Inc., 2025) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K072765.
How does its category compare?
All LIT devicesLIT Catheter, Angioplasty, Peripheral, Transluminal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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-18 peripheral dilatation catheter is indicated to dilate stenosis in the femoral, popliteal and infrapopliteal arteries and for the treatment of obstructive lesions of 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/K151744 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151744: Passeo-18 Peripheral Dilation Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151744
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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