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 11, 2002 as substantially equivalent to K001577 (Lumend, Inc., 2001) after a 28-day review. Its family tree reaches back 1 generation to 2001. 8 later devices descend from it. It has been recalled once.
- Decided
- Jan 11, 2002
- Review
- 28 days
- Class
- Class II
- Product code
- DQY
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K001577 (2001). 8 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK001577 Outback CatheterLumend, Inc. · 2001 · Recalled
- This deviceK014117 Modification to Outback CatheterLumend, Inc. · 2002
- Descendant · cites it directly · 7 of its ownK032298 Modification to Outback CatheterLumend, Inc. · 2003 · Recalled
- Descendant · 2 generations on · 6 of its ownK040771 Modification to Outback CatheterLumend, Inc. · 2004 · Recalled
- Descendant · 2 generations on · 5 of its ownK043534 Modification to Outback CatheterLumend, Inc. · 2005 · Recalled
- Descendant · 3 generations on · 4 of its ownK083814 Outback LTD RE-Entry Catheter, Model: OTB42120Cordis Corp., A Johnson & Johnson Co. · 2009
- Descendant · 4 generations on · 2 of its ownK150836 OUTBACK Elite Re-Entry CatheterCordis Corporation, A Johnson & Johnson Co. · 2015
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K032298Modification to Outback CatheterLumend, Inc. · 2003 · cites it directly7descendants
- K040771Modification to Outback CatheterLumend, Inc. · 2004 · 2 generations on6descendants
- K043534Modification to Outback CatheterLumend, Inc. · 2005 · 2 generations on5descendants
- K083814Outback LTD RE-Entry Catheter, Model: OTB42120Cordis Corp., A Johnson & Johnson Co. · 2009 · 3 generations on4descendants
- K150836OUTBACK Elite Re-Entry CatheterCordis Corporation, A Johnson & Johnson Co. · 2015 · 4 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K001577 | Outback Catheter | Lumend, Inc. | 2001 | 1 |
| 0 (this device) | K014117 | Modification to Outback Catheter | Lumend, Inc. | 2002 | — |
| +1 | K032298 | Modification to Outback Catheter | Lumend, Inc. | 2003 | 2 |
| +2 | K040771 | Modification to Outback Catheter | Lumend, Inc. | 2004 | 1 |
| +2 | K043534 | Modification to Outback Catheter | Lumend, Inc. | 2005 | 1 |
| +3 | K083814 | Outback LTD RE-Entry Catheter, Model: OTB42120 | Cordis Corp., A Johnson & Johnson Co. | 2009 | — |
| +4 | K150836 | OUTBACK Elite Re-Entry Catheter | Cordis Corporation, A Johnson & Johnson Co. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K001577 | Outback CatheterSummary page 1…Percutaneous Catheter Classification: Class II Classification Name: Percutaneous Catheter, 21 CFR Part 870.1250 Product Code: 74DQY Predicate Device: Outback™ Catheter (K001577) Intended Use: The Outback Catheter is intended to facilitate placement and positioning of catheters within the peripheral vascu… | 2001 |
What descends from it? (8)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K032298 | Modification to Outback Catheter | 2003 | 7 |
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?
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 catheters within the peripheral vasculature. The Outback 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/K014117 · printed Nov 6, 2026
Cite this page
510(k) Report. “K014117: 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/K014117
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026