510(k) Report

510(k) · Cleared

Recalled · 2008

Modification to Outback Catheter

K040771510(k) SpecialCleared Apr 23, 200429-day reviewClass II21 CFR 870.1250Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Lumend, Inc. · DQY Catheter, Percutaneous

Cleared on Apr 23, 2004 as substantially equivalent to K032298 (Lumend, Inc., 2003) after a 29-day review. Its family tree reaches back 3 generations to 2001. 6 later devices descend from it. It has been recalled once.

Decided
Apr 23, 2004
Review
29 days
Class
Class II
Product code
DQY
Recalls
1
Predicates
1

Its longest line of descent runs back 3 generations to K001577 (2001). 6 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2005: 1 descendant cleared2009: 1 descendant cleared2015: 1 descendant cleared2013: 1 descendant cleared2022: 1 descendant cleared2025: 1 descendant clearedK001577 · Outback Catheter · Lumend, Inc. · 2001 · recalledK014117 · Modification to Outback Catheter · Lumend, Inc. · 2002 · recalledK032298 · Modification to Outback Catheter · Lumend, Inc. · 2003 · recalled200020052010201520202025
Descendants, by generation 1 generation forward: 1 descendant2 generations forward: 1 descendant3 generations forward: 2 descendants4 generations forward: 1 descendant5 generations forward: 1 descendant K032298 · Modification to Outback Catheter · Lumend, Inc. · 2003 · recalledK014117 · Modification to Outback Catheter · Lumend, Inc. · 2002 · recalledK001577 · Outback Catheter · Lumend, Inc. · 2001 · recalled0+5
  1. Root · 3 generations backK001577 Outback CatheterLumend, Inc. · 2001 · Recalled
  2. 2 generations backK014117 Modification to Outback CatheterLumend, Inc. · 2002 · Recalled
  3. 1 generation backK032298 Modification to Outback CatheterLumend, Inc. · 2003 · Recalled
  4. This deviceK040771 Modification to Outback CatheterLumend, Inc. · 2004
  5. Descendant · cites it directly · 5 of its ownK043534 Modification to Outback CatheterLumend, Inc. · 2005 · Recalled
  6. Descendant · 2 generations on · 4 of its ownK083814 Outback LTD RE-Entry Catheter, Model: OTB42120Cordis Corp., A Johnson & Johnson Co. · 2009
  7. Descendant · 3 generations on · 2 of its ownK150836 OUTBACK Elite Re-Entry CatheterCordis Corporation, A Johnson & Johnson Co. · 2015
  8. Descendant · 4 generations on · 1 of its ownK221541 LimFlow ARCLimFlow, Inc. · 2022
  9. Descendant · 5 generations on · 0 of its ownK251376 LimFlow ARCLimFlow, Inc. · 2025

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2005: 12009: 12013: 12015: 12022: 12025: 1
2005high 1 (2005) · low 0 (2006)2026

Most influential descendants

Showing 5 of 6 · See all
  • 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
  • K251376LimFlow ARCLimFlow, Inc. · 2025 · 5 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K001577Outback CatheterLumend, Inc.20011
−2K014117Modification to Outback CatheterLumend, Inc.20021
−1K032298Modification to Outback CatheterLumend, Inc.20032
0 (this device)K040771Modification to Outback CatheterLumend, Inc.2004—
+1K043534Modification to Outback CatheterLumend, Inc.20051
+2K083814Outback LTD RE-Entry Catheter, Model: OTB42120Cordis Corp., A Johnson & Johnson Co.2009—
+3K150836OUTBACK Elite Re-Entry CatheterCordis Corporation, A Johnson & Johnson Co.2015—
+4K221541LimFlow ARCLimFlow, Inc.2022—
+5K251376LimFlow ARCLimFlow, Inc.2025—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
200910
201310
201510
202210
202510
FIG. 1 — Lineage of K040771, 2001–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K234115 APRO 55 Catheterscore 17.5 · 6 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K032298Modification to Outback Catheter
Summary page 1
…e Outback® Catheter is substantially equivalent in intended use and method of operation to the following predicate devices: LuMend Outback® Catheter cleared via 510(k) K032298 on 8/26/04 Device Description: The Outback® catheter is a sterile, single use device comprised of three primary elements. 1)…
Lumend, Inc.20032

Also cleared against K032298: 1 other device →

What descends from it? (6)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K043534Modification to Outback CatheterLumend, Inc.20055

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Aug 20, 2008Not classifiedZ-0279-2009OtherThe 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 3 years and passes through 1 company; a new generation was cleared every 12 months on median.
  • 3 of the 3 ancestors have a recall of any class.
  • Of its descendants, K043534 (Lumend, Inc., 2005) has gone furthest, with 5 descendants of its own.
  • 1 other device also cites its predicate K032298.

How does its category compare?

All DQY devices

DQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DQY

21in 2025

2007: 162008: 312009: 372010: 222011: 362012: 302013: 322014: 192015: 272016: 222017: 262018: 252019: 302020: 202021: 182022: 182023: 182024: 162025: 212026 (partial year): 11
2007high 37 (2009) · low 16 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DQY

115in 2025

2007: 85 days median2008: 66 days median2009: 73 days median2010: 74 days median2011: 71 days median2012: 87 days median2013: 92 days median2014: 127 days median2015: 118 days median2016: 117 days median2017: 113 days median2018: 106 days median2019: 111 days median2020: 120 days median2021: 81 days median2022: 74 days median2023: 114 days median2024: 87 days median2025: 115 days median2026 (partial year): 30 days median
2007high 127 (2014) · low 66 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DQY

1in 2025

2007: 62008: 122009: 172010: 322011: 62012: 22013: 36, 1 Class I2014: 32015: 32016: 22, 7 Class I2017: 82018: 22019: 12020: 22021: 22023: 172024: 12025: 1, 1 Class I2026 (partial year): 2, 1 Class I
2007high 36 (2013) · low 0 (2022)2026

Class I (10 since 2007) Class II/III not classified

Adverse event reports per year · DQY

3,056in 2025

2007: 3132008: 4962009: 8192010: 1,2932011: 1,2112012: 1,1912013: 1,3522014: 1,4972015: 2,3372016: 2,2522017: 2,4892018: 2,8552019: 2,9022020: 2,8892021: 3,0062022: 2,6432023: 3,0492024: 3,1902025: 3,056
2007high 3,190 (2024) · low 313 (2007)2025

MAUDE reports naming product code DQY, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200716856313
2008316612496
2009377317819
20102274321,293
2011367161,211
2012308721,191
2013329236 (1)1,352
20141912731,497
20152711832,337
20162211722 (7)2,252
20172611382,489
20182510622,855
20193011112,902
20202012022,889
2021188123,006
2022187402,643
202318114173,049
2024168713,190
2025211151 (1)3,056
202611302 (1)—

What is it indicated for?

The Outback ® Catheter is intended to facilitate placement and positioning of

guidewires/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.

Also cleared against K032298

1 other device cites the same predicate.

  • K043534Modification to Outback CatheterLumend, Inc. · 20051 recall

More from Lumend, Inc.

11 FDA decisions under this applicant name. See the company

  • K043534Modification to Outback CatheterLumend, Inc. · 20051 recall
  • K033535Lumend Frontrunner Cto Catheter and AccessoriesLumend, Inc. · 2004
  • K032298Modification to Outback CatheterLumend, Inc. · 20032 recalls
  • K031005Lumend Frontrunner GW Cto CatheterLumend, Inc. · 2003
  • K023114Lumend Frontrunner Cto CatheterLumend, Inc. · 2003

Recent decisions in DQY

The DQY category page

  • K262817CrossFAST Integrated Microcatheter Advanced Delivery SystemVantis Vascular, Inc. · 2026
  • K260559NHanceITIMDS Operation B.V. · 2026
  • K262392APRO 35 Swift CatheterAlembic, LLC · 2026
  • K261766CPS Locator 3D Plus Delivery CatheterCenterPoint Systems, LLC · 2026
  • K262240SSPC NXT Delivery CatheterCenterPoint Systems, LLC · 2026

https://510kreport.com/device/K040771 · printed Nov 3, 2026

Cite this page

510(k) Report. “K040771: Modification to Outback Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K040771

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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