510(k) · Cleared
ClearedPasseo-14 Peripheral Dilatation 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 K142379 (Biotronik, Inc., 2014) after a 59-day review. Its family tree reaches back 6 generations to 2000. 1 later device descends from it.
- Decided
- Oct 8, 2015
- Review
- 59 days
- Class
- Class II
- Product code
- LIT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K000101 (2000). 9 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backK000101 RX Viatrac 14 Peripheral Dilatation CatheterGuidant Corp. · 2000
- 5 generations backK020854 Modification to Fox Pta CatheterJomed AG · 2002
- 4 generations backK033217 Pheron Pta CatheterBiotronik, Inc. · 2003
- 3 generations backK072765 Passeo 18Biotronik, Inc. · 2007
- 2 generations backK082933 Passeo-35 Pta CatheterBiotronik, Inc. · 2008
- 1 generation backK142379 Passeo-35 PTA CatheterBiotronik, Inc. · 2014
- This deviceK152240 Passeo-14 Peripheral Dilatation 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 |
|---|---|---|---|---|---|
| −6 | K000101 | RX Viatrac 14 Peripheral Dilatation Catheter | Guidant Corp. | 2000 | — |
| −5 | K020854 | Modification to Fox Pta Catheter | Jomed AG | 2002 | — |
| −4 | K033217 | Pheron Pta Catheter | Biotronik, Inc. | 2003 | — |
| −3 | K072765 | Passeo 18 | Biotronik, Inc. | 2007 | — |
| −2 | K082933 | Passeo-35 Pta Catheter | Biotronik, Inc. | 2008 | — |
| −1 | K142379 | Passeo-35 PTA Catheter | Biotronik, Inc. | 2014 | — |
| 0 (this device) | K152240 | Passeo-14 Peripheral Dilatation 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 |
|---|---|---|---|
| * | K142379 | Passeo-35 PTA CatheterSummary page 4…Manufacturer Date of Clearance Predicate K142379 Passeo-35 BIOTRONIK 5-Dec-2014 Reference K083919 A… | 2014 |
| † | K083919 | Amphirion Deep 0.014 Otw Pta Balloon Catheter | 2009 |
| † | K090849 | Modification to: Nanocross 0.14 Otw Pta Dilatation Catheter, Models AB14W020210090… | 2009 |
| † | K093139 | Bantam,48XXXXXX, 50XXXXXX | 2009 |
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 2.2 years on median.
- None of the 9 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 K142379.
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-14 is indicated for balloon dilatation of the stenotic portion of a lower limb artery for the purpose of
improving perfusion.
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/K152240 · printed Nov 3, 2026
Cite this page
510(k) Report. “K152240: Passeo-14 Peripheral Dilatation Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K152240
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