510(k) · Cleared
ClearedOutback LTD RE-Entry Catheter, Model: OTB42120
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cordis Corp., A Johnson & Johnson Co. · PDU Catheter For Crossing Total Occlusions
Cleared on Jan 13, 2009 as substantially equivalent to K043534 (Lumend, Inc., 2005) after a 22-day review. Its family tree reaches back 5 generations to 2001. 4 later devices descend from it.
- Decided
- Jan 13, 2009
- Review
- 22 days
- Class
- Class II
- Product code
- PDU
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K001577 (2001). 4 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK001577 Outback CatheterLumend, Inc. · 2001 · Recalled
- 4 generations backK014117 Modification to Outback CatheterLumend, Inc. · 2002 · Recalled
- 3 generations backK032298 Modification to Outback CatheterLumend, Inc. · 2003 · Recalled
- 2 generations backK040771 Modification to Outback CatheterLumend, Inc. · 2004 · Recalled
- 1 generation backK043534 Modification to Outback CatheterLumend, Inc. · 2005 · Recalled
- This deviceK083814 Outback LTD RE-Entry Catheter, Model: OTB42120Cordis Corp., A Johnson & Johnson Co. · 2009
- Descendant · cites it directly · 2 of its ownK150836 OUTBACK Elite Re-Entry CatheterCordis Corporation, A Johnson & Johnson Co. · 2015
- Descendant · 2 generations on · 1 of its ownK221541 LimFlow ARCLimFlow, Inc. · 2022
- Descendant · 3 generations on · 0 of its ownK251376 LimFlow ARCLimFlow, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK131914 Offroad RE-Entry Catheter SystemBoston Scientific Corp · 2013
Most influential descendants
Showing 4 of 4 · See all- K150836OUTBACK Elite Re-Entry CatheterCordis Corporation, A Johnson & Johnson Co. · 2015 · cites it directly2descendants
- K221541LimFlow ARCLimFlow, Inc. · 2022 · 2 generations on1descendant
- K251376LimFlow ARCLimFlow, Inc. · 2025 · 3 generations on0descendants
- K131914Offroad RE-Entry Catheter SystemBoston Scientific Corp · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K001577 | Outback Catheter | Lumend, Inc. | 2001 | 1 |
| −4 | K014117 | Modification to Outback Catheter | Lumend, Inc. | 2002 | 1 |
| −3 | K032298 | Modification to Outback Catheter | Lumend, Inc. | 2003 | 2 |
| −2 | K040771 | Modification to Outback Catheter | Lumend, Inc. | 2004 | 1 |
| −1 | K043534 | Modification to Outback Catheter | Lumend, Inc. | 2005 | 1 |
| 0 (this device) | K083814 | Outback LTD RE-Entry Catheter, Model: OTB42120 | Cordis Corp., A Johnson & Johnson Co. | 2009 | — |
| +1 | K150836 | OUTBACK Elite Re-Entry Catheter | Cordis Corporation, A Johnson & Johnson Co. | 2015 | — |
| +2 | K221541 | LimFlow ARC | LimFlow, Inc. | 2022 | — |
| +3 | K251376 | LimFlow ARC | LimFlow, Inc. | 2025 | — |
| +1 | K131914 | Offroad RE-Entry Catheter System | Boston Scientific Corp | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2022 | 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 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 |
|---|---|---|---|
| * | K043534 | Modification to Outback CatheterSummary page 1…l Name ‘ Outback@ LTD™ Re-Entry Catheter Catheter, percutaneous 21 CFR 870.1250 The device is substanually eqmvalent to: . e Outback LTD IRe-Entry Catheter (5 10(k) # K043534) ClassI S Performance standards have not been estabhshed by the FDA under sectlon 514 of the Food, Dmg and Cosmetic Act. “The… | 2005 |
What descends from it? (4)
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 8 years and passes through 2 companies; a new generation was cleared every 12 months on median.
- 5 of the 5 ancestors have a recall of any class.
- Of its descendants, K150836 (Cordis Corporation, A Johnson & Johnson Co., 2015) has gone furthest, with 2 descendants of its own.
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. 2009, 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 Outback LTD Re-Entry Catheter is intended to facilitate placement and positioning of guidewires and catheters within the peripheral vasculature. The Outback LTD Re-Entry Catheter is not intended for use in the coronary or cerebral vasculature.
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/K083814 · printed Nov 5, 2026
Cite this page
510(k) Report. “K083814: Outback LTD RE-Entry Catheter, Model: OTB42120.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K083814
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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