510(k) · Cleared
ClearedOffroad RE-Entry Catheter System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corp · PDU Catheter For Crossing Total Occlusions
Cleared on Oct 31, 2013 as substantially equivalent to K083814 (Cordis Corp., A Johnson & Johnson Co., 2009) after a 127-day review. Its family tree reaches back 6 generations to 2001.
- Decided
- Oct 31, 2013
- Review
- 127 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 backK014117 Modification to Outback CatheterLumend, Inc. · 2002 · Recalled
- 4 generations backK032298 Modification to Outback CatheterLumend, Inc. · 2003 · Recalled
- 3 generations backK040771 Modification to Outback CatheterLumend, Inc. · 2004 · Recalled
- 2 generations backK043534 Modification to Outback CatheterLumend, Inc. · 2005 · Recalled
- 1 generation backK083814 Outback LTD RE-Entry Catheter, Model: OTB42120Cordis Corp., A Johnson & Johnson Co. · 2009
- This deviceK131914 Offroad RE-Entry Catheter SystemBoston Scientific Corp · 2013
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 | K014117 | Modification to Outback Catheter | Lumend, Inc. | 2002 | 1 |
| −4 | K032298 | Modification to Outback Catheter | Lumend, Inc. | 2003 | 2 |
| −3 | K040771 | Modification to Outback Catheter | Lumend, Inc. | 2004 | 1 |
| −2 | K043534 | Modification to Outback Catheter | Lumend, Inc. | 2005 | 1 |
| −1 | K083814 | Outback LTD RE-Entry Catheter, Model: OTB42120 | Cordis Corp., A Johnson & Johnson Co. | 2009 | — |
| 0 (this device) | K131914 | Offroad RE-Entry Catheter System | Boston Scientific Corp | 2013 | — |
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 |
|---|---|---|---|
| * | K083814 | Outback LTD RE-Entry Catheter, Model: OTB42120Summary page 1…ng Total Occlusions Classification Class 11,21 CER Part 870.1250 - Percutaneous Catheter Predicate Device Cordis Outback Re-Entry Catheter K083814 January 13, 2009 Device The OffRoad Re-Entry Catheter System consists of two components: Description… | 2009 |
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 12 years and passes through 3 companies; a new generation was cleared every 1.6 years on median.
- 5 of the 6 ancestors have a recall of any class.
- 1 other device also cites its predicate K083814.
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. 2013, 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 OffRoad Re-Entry Catheter System is intended to facilitate the placement and positioning of guidewires within the peripheral vasculature beyond stenotic lesions, including sub and chronic total occlusions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131914 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131914: Offroad RE-Entry Catheter System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131914
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