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 Aug 26, 2003 as substantially equivalent to K001577 (Lumend, Inc., 2001) and 1 other predicate after a 32-day review. Its family tree reaches back 2 generations to 2001. 7 later devices descend from it. It has been recalled 2 times.
- Decided
- Aug 26, 2003
- Review
- 32 days
- Class
- Class II
- Product code
- DQY
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 2 generations to K001577 (2001). 7 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK001577 Outback CatheterLumend, Inc. · 2001 · Recalled
- 1 generation backK014117 Modification to Outback CatheterLumend, Inc. · 2002 · Recalled
- This deviceK032298 Modification to Outback CatheterLumend, Inc. · 2003
- Descendant · cites it directly · 6 of its ownK040771 Modification to Outback CatheterLumend, Inc. · 2004 · Recalled
- Descendant · cites it directly · 5 of its ownK043534 Modification to Outback CatheterLumend, Inc. · 2005 · Recalled
- Descendant · 2 generations on · 4 of its ownK083814 Outback LTD RE-Entry Catheter, Model: OTB42120Cordis Corp., A Johnson & Johnson Co. · 2009
- Descendant · 3 generations on · 2 of its ownK150836 OUTBACK Elite Re-Entry CatheterCordis Corporation, A Johnson & Johnson Co. · 2015
- Descendant · 4 generations on · 1 of its ownK221541 LimFlow ARCLimFlow, Inc. · 2022
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K040771Modification to Outback CatheterLumend, Inc. · 2004 · cites it directly6descendants
- K043534Modification to Outback CatheterLumend, Inc. · 2005 · cites it directly5descendants
- K083814Outback LTD RE-Entry Catheter, Model: OTB42120Cordis Corp., A Johnson & Johnson Co. · 2009 · 2 generations on4descendants
- K150836OUTBACK Elite Re-Entry CatheterCordis Corporation, A Johnson & Johnson Co. · 2015 · 3 generations on2descendants
- K221541LimFlow ARCLimFlow, Inc. · 2022 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K001577 | Outback Catheter | Lumend, Inc. | 2001 | 1 |
| −1 | K014117 | Modification to Outback Catheter | Lumend, Inc. | 2002 | 1 |
| 0 (this device) | K032298 | Modification to Outback Catheter | Lumend, Inc. | 2003 | — |
| +1 | K040771 | Modification to Outback Catheter | Lumend, Inc. | 2004 | 1 |
| +1 | K043534 | Modification to Outback Catheter | Lumend, Inc. | 2005 | 1 |
| +2 | K083814 | Outback LTD RE-Entry Catheter, Model: OTB42120 | Cordis Corp., A Johnson & Johnson Co. | 2009 | — |
| +3 | K150836 | OUTBACK Elite Re-Entry Catheter | Cordis Corporation, A Johnson & Johnson Co. | 2015 | — |
| +4 | K221541 | LimFlow ARC | LimFlow, Inc. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K001577 | Outback CatheterSummary page 2…e(s): The LuMend Outback@Catheter is essentially identical to the Abbott Laboratories Outback@ Catheter (KO141 17). This Abbott device was originally cleared via 510(k) K001577. After LuMend’s reacquisition of the Outback@Catheter from Abbott, a few minor changes have been made (see detailed device descri… | 2001 |
| * | K014117 | Modification to Outback Catheter | 2002 |
What descends from it? (7)
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)
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… |
| May 18, 2004 | Not classified | Z-0995-04 | Other | Recall initiated after Lumend received a report of a malfunction of an Outback Catheter in Ohio. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 2 years and passes through 1 company; a new generation was cleared every 1.6 years on median.
- 2 of the 2 ancestors have a recall of any class.
- Of its descendants, K040771 (Lumend, Inc., 2004) has gone furthest, with 6 descendants of its own.
- 4 other devices also cite its predicate K001577.
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/K032298 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032298: Modification to Outback Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032298
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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