510(k) · Cleared
Recalled · 2008Modification to Outback Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lumend, Inc. · DQY Catheter, Percutaneous
Cleared on Jan 21, 2005 as substantially equivalent to K040771 (Lumend, Inc., 2004) and 1 other predicate after a 30-day review. Its family tree reaches back 4 generations to 2001. 5 later devices descend from it. It has been recalled once.
- Decided
- Jan 21, 2005
- Review
- 30 days
- Class
- Class II
- Product code
- DQY
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 4 generations to K001577 (2001). 5 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK001577 Outback CatheterLumend, Inc. · 2001 · Recalled
- 3 generations backK014117 Modification to Outback CatheterLumend, Inc. · 2002 · Recalled
- 2 generations backK032298 Modification to Outback CatheterLumend, Inc. · 2003 · Recalled
- 1 generation backK040771 Modification to Outback CatheterLumend, Inc. · 2004 · Recalled
- This deviceK043534 Modification to Outback CatheterLumend, Inc. · 2005
- Descendant · cites it directly · 4 of its ownK083814 Outback LTD RE-Entry Catheter, Model: OTB42120Cordis Corp., A Johnson & Johnson Co. · 2009
- Descendant · 2 generations on · 2 of its ownK150836 OUTBACK Elite Re-Entry CatheterCordis Corporation, A Johnson & Johnson Co. · 2015
- Descendant · 3 generations on · 1 of its ownK221541 LimFlow ARCLimFlow, Inc. · 2022
- Descendant · 4 generations on · 0 of its ownK251376 LimFlow ARCLimFlow, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK131914 Offroad RE-Entry Catheter SystemBoston Scientific Corp · 2013
Most influential descendants
Showing 5 of 5 · See all- K083814Outback LTD RE-Entry Catheter, Model: OTB42120Cordis Corp., A Johnson & Johnson Co. · 2009 · cites it directly4descendants
- K150836OUTBACK Elite Re-Entry CatheterCordis Corporation, A Johnson & Johnson Co. · 2015 · 2 generations on2descendants
- K221541LimFlow ARCLimFlow, Inc. · 2022 · 3 generations on1descendant
- K251376LimFlow ARCLimFlow, Inc. · 2025 · 4 generations on0descendants
- K131914Offroad RE-Entry Catheter SystemBoston Scientific Corp · 2013 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K001577 | Outback Catheter | Lumend, Inc. | 2001 | 1 |
| −3 | K014117 | Modification to Outback Catheter | Lumend, Inc. | 2002 | 1 |
| −2 | K032298 | Modification to Outback Catheter | Lumend, Inc. | 2003 | 2 |
| −1 | K040771 | Modification to Outback Catheter | Lumend, Inc. | 2004 | 1 |
| 0 (this device) | K043534 | Modification to Outback Catheter | Lumend, Inc. | 2005 | — |
| +1 | K083814 | Outback LTD RE-Entry Catheter, Model: OTB42120 | Cordis Corp., A Johnson & Johnson Co. | 2009 | — |
| +2 | K150836 | OUTBACK Elite Re-Entry Catheter | Cordis Corporation, A Johnson & Johnson Co. | 2015 | — |
| +3 | K221541 | LimFlow ARC | LimFlow, Inc. | 2022 | — |
| +4 | K251376 | LimFlow ARC | LimFlow, Inc. | 2025 | — |
| +2 | K131914 | Offroad RE-Entry Catheter System | Boston Scientific Corp | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 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 DQY? 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 DQY device
- #1 K234115 APRO 55 Catheterscore 17.5 · 6 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 |
|---|---|---|---|
| * | K040771 | Modification to Outback CatheterSummary page 1…to the following predicate devices: LuMend Outback Catheter cleared via 5 10(k) K040771 on 4/23/04 and K032298 on 8/26/03 Device Description: The Outback ® catheter is a s… | 2004 |
| * | K032298 | Modification to Outback CatheterSummary page 1…to the following predicate devices: LuMend Outback Catheter cleared via 5 10(k) K040771 on 4/23/04 and K032298 on 8/26/03 Device Description: The Outback ® catheter is a sterile, single use device comprised of three primary elements.… | 2003 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K083814 | Outback LTD RE-Entry Catheter, Model: OTB42120 | 2009 | 4 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 20, 2008 | Not classified | Z-0279-2009 | Other | The Cordis LuMend Outback LTD Re-Entry Catheter - separation rate of the cannula to the deployment slide of the handle assembly is higher than anticipated. The cannula is unable to be retracted into the device after deployment due to a… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 4 years and passes through 1 company; a new generation was cleared every 12 months on median.
- 4 of the 4 ancestors have a recall of any class.
- Of its descendants, K083814 (Cordis Corp., A Johnson & Johnson Co., 2009) has gone furthest, with 4 descendants of its own.
How does its category compare?
All DQY devicesDQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DQY
21in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DQY
115in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQY
1in 2025
Class I (10 since 2007) Class II/III not classified
Adverse event reports per year · DQY
3,056in 2025
MAUDE reports naming product code DQY, 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 | 16 | 85 | 6 | 313 |
| 2008 | 31 | 66 | 12 | 496 |
| 2009 | 37 | 73 | 17 | 819 |
| 2010 | 22 | 74 | 32 | 1,293 |
| 2011 | 36 | 71 | 6 | 1,211 |
| 2012 | 30 | 87 | 2 | 1,191 |
| 2013 | 32 | 92 | 36 (1) | 1,352 |
| 2014 | 19 | 127 | 3 | 1,497 |
| 2015 | 27 | 118 | 3 | 2,337 |
| 2016 | 22 | 117 | 22 (7) | 2,252 |
| 2017 | 26 | 113 | 8 | 2,489 |
| 2018 | 25 | 106 | 2 | 2,855 |
| 2019 | 30 | 111 | 1 | 2,902 |
| 2020 | 20 | 120 | 2 | 2,889 |
| 2021 | 18 | 81 | 2 | 3,006 |
| 2022 | 18 | 74 | 0 | 2,643 |
| 2023 | 18 | 114 | 17 | 3,049 |
| 2024 | 16 | 87 | 1 | 3,190 |
| 2025 | 21 | 115 | 1 (1) | 3,056 |
| 2026 | 11 | 30 | 2 (1) | — |
What is it indicated for?
The Outback® Catheter is intended to facilitate placement® and positioning of guide wires/
catheters within the peripheral vasculature. The Outback Catheter is not intended for
use in the coronary or cerebral vasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043534 · printed Nov 5, 2026
Cite this page
510(k) Report. “K043534: Modification to Outback Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K043534
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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