510(k) · Cleared
ClearedPasseo 18
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 Dec 12, 2007 as substantially equivalent to K033217 (Biotronik, Inc., 2003) and 1 other predicate after a 75-day review. Its family tree reaches back 3 generations to 2000. 7 later devices descend from it.
- Decided
- Dec 12, 2007
- Review
- 75 days
- Class
- Class II
- Product code
- LIT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K000101 (2000). 6 ancestors in all. 7 later devices descend from it, 2 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 backK033217 Pheron Pta CatheterBiotronik, Inc. · 2003
- This deviceK072765 Passeo 18Biotronik, Inc. · 2007
- Descendant · cites it directly · 5 of its ownK082933 Passeo-35 Pta CatheterBiotronik, Inc. · 2008
- Descendant · 2 generations on · 3 of its ownK142379 Passeo-35 PTA CatheterBiotronik, Inc. · 2014
- Descendant · 3 generations on · 1 of its ownK222065 Passeo-35 Xeo Peripheral Dilatation CatheterBiotronik, Inc. · 2023
- Descendant · cites it directly · 1 of its ownK151744 Passeo-18 Peripheral Dilation CatheterBiotronik, Inc. · 2015
- Descendant · 3 generations on · 1 of its ownK152240 Passeo-14 Peripheral Dilatation CatheterBiotronik, Inc. · 2015
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K082933Passeo-35 Pta CatheterBiotronik, Inc. · 2008 · cites it directly5descendants
- K142379Passeo-35 PTA CatheterBiotronik, Inc. · 2014 · 2 generations on3descendants
- K222065Passeo-35 Xeo Peripheral Dilatation CatheterBiotronik, Inc. · 2023 · 3 generations on1descendant
- K151744Passeo-18 Peripheral Dilation CatheterBiotronik, Inc. · 2015 · cites it directly1descendant
- K152240Passeo-14 Peripheral Dilatation CatheterBiotronik, Inc. · 2015 · 3 generations on1descendant
View 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 | K033217 | Pheron Pta Catheter | Biotronik, Inc. | 2003 | — |
| 0 (this device) | K072765 | Passeo 18 | Biotronik, Inc. | 2007 | — |
| +1 | K082933 | Passeo-35 Pta Catheter | Biotronik, Inc. | 2008 | — |
| +2 | K142379 | Passeo-35 PTA Catheter | Biotronik, Inc. | 2014 | — |
| +3 | K222065 | Passeo-35 Xeo Peripheral Dilatation Catheter | Biotronik, Inc. | 2023 | — |
| +1 | K151744 | Passeo-18 Peripheral Dilation Catheter | Biotronik, Inc. | 2015 | — |
| +3 | K152240 | Passeo-14 Peripheral Dilatation Catheter | Biotronik, Inc. | 2015 | — |
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 |
|---|---|---|
| 2008 | 1 | 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? (2)
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 |
|---|---|---|---|
| * | K033217 | Pheron Pta CatheterSummary page 1…OTRONIK proposes its Pheron peripheral PTA catheter cleared through the following 510(k) notifications as the predicate device for the Passeo-1 8 PTA Catheter: * K033217, cleared October 31, 2003 * K052757, cleared October 28, 2005 Indication for Use: The Passeo-18 peripheral dilatation cat… | 2003 |
| * | K052757 | Pheron Peripheral Percutaneous Transluminal Angioplasty (Pta) CatheterSummary page 1…atheter cleared through the following 510(k) notifications as the predicate device for the Passeo-1 8 PTA Catheter: * K033217, cleared October 31, 2003 * K052757, cleared October 28, 2005 Indication for Use: The Passeo-18 peripheral dilatation catheter is indicated to dilate stenosis in the… | 2005 |
What descends from it? (7)
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 7 years and passes through 3 companies; a new generation was cleared every 2.2 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K082933 (Biotronik, Inc., 2008) has gone furthest, with 5 descendants of its own.
- 1 other device also cites its predicate K033217.
How does its category compare?
All LIT devicesLIT Catheter, Angioplasty, Peripheral, Transluminal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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?
Passeo-18 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 as stated in the FDA summary.
https://510kreport.com/device/K072765 · printed Nov 4, 2026
Cite this page
510(k) Report. “K072765: Passeo 18.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K072765
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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