510(k) · Cleared
ClearedPioneer Plus Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Volcano · PDU Catheter For Crossing Total Occlusions
Cleared on Dec 2, 2016 as substantially equivalent to K101777 (Medtronic Vascular, 2010) after a 94-day review. Its family tree reaches back 6 generations to 2001.
- Decided
- Dec 2, 2016
- Review
- 94 days
- Class
- Class II
- Product code
- PDU
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K001577 (2001). No later device cites it as a predicate yet.
- Root · 6 generations backK001577 Outback CatheterLumend, Inc. · 2001 · Recalled
- 5 generations backK013363 Crosspoint Transaccess CatheterTrans Vascular Incorporated · 2002
- 4 generations backK031920 Crosspoint Transaccess Catheter, Model TA-XP-001Trans Vascular Incorporated · 2003 · Recalled
- 3 generations backK072155 Pioneer CatheterMedtronic, Inc. · 2007
- 2 generations backK081804 Pioneer Plus CatheterMedtronic, Inc. · 2008 · Recalled
- 1 generation backK101777 Pioneer Plus Catheter, Model Plus 120Medtronic Vascular · 2010 · Recalled
- This deviceK162418 Pioneer Plus CatheterPhilips Volcano · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K001577 | Outback Catheter | Lumend, Inc. | 2001 | 1 |
| −5 | K013363 | Crosspoint Transaccess Catheter | Trans Vascular Incorporated | 2002 | — |
| −4 | K031920 | Crosspoint Transaccess Catheter, Model TA-XP-001 | Trans Vascular Incorporated | 2003 | 1 |
| −3 | K072155 | Pioneer Catheter | Medtronic, Inc. | 2007 | — |
| −2 | K081804 | Pioneer Plus Catheter | Medtronic, Inc. | 2008 | 2 |
| −1 | K101777 | Pioneer Plus Catheter, Model Plus 120 | Medtronic Vascular | 2010 | 1 |
| 0 (this device) | K162418 | Pioneer Plus Catheter | Philips Volcano | 2016 | — |
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 PDU? 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 PDU device
- #1 K262013 Kiba CTO Crossing Catheterscore 15.2 · 12 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 |
|---|---|---|---|
| * | K101777 | Pioneer Plus Catheter, Model Plus 120Summary page 4…II PDU 21 CFR 892.1570 Diagnostic Ultrasound Transducer II ITX PREDICATE DEVICE: 510(k) Number: K101777 Trade Name: Pioneer Plus Catheter Common Name: Diagnostic Ultrasou… | 2010 |
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 15 years and passes through 5 companies; a new generation was cleared every 2.0 years on median.
- 4 of the 6 ancestors have a recall of any class.
How does its category compare?
All PDU devicesPDU Catheter For Crossing Total Occlusions: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · PDU
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PDU
59in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PDU
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PDU
179in 2025
MAUDE reports naming product code PDU, 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 | 4 | 66 | 0 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 3 | 49 | 0 | 0 |
| 2011 | 3 | 91 | 0 | 0 |
| 2012 | 6 | 68 | 0 | 0 |
| 2013 | 1 | — | 0 | 3 |
| 2014 | 3 | 97 | 0 | 10 |
| 2015 | 2 | — | 0 | 12 |
| 2016 | 2 | — | 0 | 26 |
| 2017 | 1 | — | 0 | 211 |
| 2018 | 0 | — | 0 | 97 |
| 2019 | 1 | — | 0 | 83 |
| 2020 | 2 | — | 2 | 129 |
| 2021 | 3 | 144 | 0 | 189 |
| 2022 | 4 | 139 | 0 | 156 |
| 2023 | 3 | 221 | 1 | 71 |
| 2024 | 1 | — | 0 | 92 |
| 2025 | 3 | 59 | 0 | 179 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Pioneer Plus catheter is intended to facilitate placement and positioning of catheters within the peripheral vasculature. The Pioneer Plus catheter also provides an intraluminal cross-sectional ultrasound image of the area of interest to facilitate placement of guidewires beyond stenotic lesions (e.g., sub-total, total or chronic total occlusions) prior to additional intervention (i.e. PTA, stent, etc.). The Pioneer Plus catheter is not indicated for use in the coronary or cerebral vasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162418 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162418: Pioneer Plus Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162418
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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