510(k) Report

510(k) · Cleared

Recalled · 2008

Outback Catheter

K001577510(k) TraditionalCleared Jan 11, 2001234-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 Jan 11, 2001 after a 234-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 24 devices in its family, counting itself, has a Class I recall. 23 later devices descend from it. It has been recalled once.

Decided
Jan 11, 2001
Review
234 days
Class
Class II
Product code
DQY
Recalls
1
Predicates
0

23 later devices descend from it, 5 citing it directly. 1 of the 24 devices in this family, counting this one, has a Class I recall.

Descendants, by year cleared 2002: 2 descendants cleared2019: 1 descendant cleared2003: 2 descendants cleared2010: 2 descendants cleared2007: 1 descendant cleared2004: 1 descendant cleared2005: 1 descendant cleared2012: 1 descendant cleared2022: 2 descendants cleared2009: 1 descendant cleared2008: 1 descendant cleared2013: 2 descendants cleared2015: 2 descendants cleared2014: 1 descendant cleared, 1 with a Class I recall12016: 1 descendant cleared2018: 1 descendant cleared2025: 1 descendant cleared200020052010201520202025
  1. This deviceK001577 Outback CatheterLumend, Inc. · 2001
  2. Descendant · cites it directly · 8 of its ownK014117 Modification to Outback CatheterLumend, Inc. · 2002 · Recalled
  3. Descendant · cites it directly · 7 of its ownK032298 Modification to Outback CatheterLumend, Inc. · 2003 · Recalled
  4. Descendant · 2 generations on · 6 of its ownK040771 Modification to Outback CatheterLumend, Inc. · 2004 · Recalled
  5. Descendant · cites it directly · 5 of its ownK101479 Wingman Extendable Tip Support CatheterReflow Medical · 2010
  6. Descendant · 2 generations on · 5 of its ownK043534 Modification to Outback CatheterLumend, Inc. · 2005 · Recalled

Showing 5 of 23 descendants. See all descendants

Descendants cleared per year

2002: 22003: 22004: 12005: 12007: 12008: 12009: 12010: 22012: 12013: 22014: 12015: 22016: 12018: 12019: 12022: 22025: 1
2002high 2 (2002) · low 0 (2006)2026

Class I recalls in this family

  • K141547 Wingman Extendable Tip Support Catheter4 generations on · 2014

Most influential descendants

Showing 5 of 23 · See all
  • K014117Modification to Outback CatheterLumend, Inc. · 2002 · cites it directly8descendants
  • K032298Modification to Outback CatheterLumend, Inc. · 2003 · cites it directly7descendants
  • K040771Modification to Outback CatheterLumend, Inc. · 2004 · 2 generations on6descendants
  • K101479Wingman Extendable Tip Support CatheterReflow Medical · 2010 · cites it directly5descendants
  • K043534Modification to Outback CatheterLumend, Inc. · 2005 · 2 generations on5descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K001577Outback CatheterLumend, Inc.2001—
+1K014117Modification to Outback CatheterLumend, Inc.20021
+1K032298Modification to Outback CatheterLumend, Inc.20032
+2K040771Modification to Outback CatheterLumend, Inc.20041
+1K101479Wingman Extendable Tip Support CatheterReflow Medical2010—
+2K043534Modification to Outback CatheterLumend, Inc.20051

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200220
200320
200410
200510
200710
200810
200910
201020
201210
201320
201411
201520
201610
201810
201910
202220
202510
FIG. 1 — Lineage of K001577, 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

1 device in this family has a Class I recall. 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
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (23)

See all 23

5 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K014117Modification to Outback CatheterLumend, Inc.20028
K032298Modification to Outback CatheterLumend, Inc.20037
K101479Wingman Extendable Tip Support CatheterReflow Medical20105
K013363Crosspoint Transaccess CatheterTrans Vascular Incorporated20025
K182937Upstream GoBack Crossing CatheterUpstream Peripheral Technologies, Ltd.20191

Has anything in its family been recalled? (1 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…

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

  • K141547Wingman Extendable Tip Support CatheterReflow Medical · 2014 · 4 generations on · ◆ in the 2014 descendants bar of FIG. 11 Class I recall

What does this lineage say?

  • Of its descendants, K014117 (Lumend, Inc., 2002) has gone furthest, with 8 descendants of its own.

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)—

More from Lumend, Inc.

11 FDA decisions under this applicant name. See the company

  • K043534Modification to Outback CatheterLumend, Inc. · 20051 recall
  • K040771Modification to Outback CatheterLumend, Inc. · 20041 recall
  • K033535Lumend Frontrunner Cto Catheter and AccessoriesLumend, Inc. · 2004
  • K032298Modification to Outback CatheterLumend, Inc. · 20032 recalls
  • K031005Lumend Frontrunner GW Cto CatheterLumend, Inc. · 2003

Recent decisions in DQY

The DQY category page

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https://510kreport.com/device/K001577 · printed Nov 6, 2026

Cite this page

510(k) Report. “K001577: 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/K001577

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026