510(k) · Cleared
ClearedWingman Extendable Tip Support Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Reflow Medical · DQY Catheter, Percutaneous
Cleared on Aug 11, 2010 as substantially equivalent to K001577 (Lumend, Inc., 2001) and 2 other predicates after a 75-day review. Its family tree reaches back 7 generations to 2000. 2 of the 24 devices in its family, counting itself, have a Class I recall. 5 later devices descend from it.
- Decided
- Aug 11, 2010
- Review
- 75 days
- Class
- Class II
- Product code
- DQY
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K001992 (2000). 18 ancestors in all, the oldest K935425 (1994). 5 later devices descend from it, 1 citing it directly. 2 of the 24 devices in this family, counting this one, have a Class I recall.
- Root · 7 generations backK001992 Ilt 0.014 Catheter, Model C114NL2Intra Luminal Therapeutics, Inc. · 2000
- 6 generations backK012169 Ilt Support Catheter .014, Model C114LW1; Ilt Support Catheter…Intra Luminal Therapeutics, Inc. · 2001
- 5 generations backK030984 Safe Cross Angled Support 0.14, Safe Cross Straight Support Catheter…Intra Luminal Therapeutics, Inc. · 2003
- 4 generations backK032660 Xtrak Support CatheterXtrak Medical, Inc. · 2003
- 3 generations backK051772 Asahi Tornus Support CatheterAsahi Intecc Co., Ltd. · 2005
- 2 generations backK070372 Gopher 2F Support Catheter, Model 5600 and Gopher 3F Support…Vascular Solutions, Inc. · 2007
- 1 generation backK091345 Gopher Gold Catheter, Model 5620Vascular Solutions, Inc. · 2009
- This deviceK101479 Wingman Extendable Tip Support CatheterReflow Medical · 2010
- Descendant · cites it directly · 4 of its ownK120178 Wingman Extendable Tip Support CatheterReflow Medical · 2012
- Descendant · 2 generations on · 3 of its ownK132420 Wingman Extendable Tip Support CatheterReflow Medical · 2013
- Descendant · 3 generations on · 2 of its ownK141547 Wingman Extendable Tip Support CatheterReflow Medical · 2014 · Recalled (Class I)
- Descendant · 4 generations on · 0 of its ownK173661 Wingman 35 Crossing CatheterReflow Medical, Inc. · 2018
- Descendant · 3 generations on · 0 of its ownK151880 Wingman Crossing CatheterReflow Medical · 2015
Class I recalls in this family
Most influential descendants
Showing 5 of 5 · See all- K120178Wingman Extendable Tip Support CatheterReflow Medical · 2012 · cites it directly4descendants
- K132420Wingman Extendable Tip Support CatheterReflow Medical · 2013 · 2 generations on3descendants
- K141547Wingman Extendable Tip Support CatheterReflow Medical · 2014 · 3 generations on2descendants
- K173661Wingman 35 Crossing CatheterReflow Medical, Inc. · 2018 · 4 generations on0descendants
- K151880Wingman Crossing CatheterReflow Medical · 2015 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K001992 | Ilt 0.014 Catheter, Model C114NL2 | Intra Luminal Therapeutics, Inc. | 2000 | — |
| −6 | K012169 | Ilt Support Catheter .014, Model C114LW1; Ilt Support Catheter Advancing… | Intra Luminal Therapeutics, Inc. | 2001 | — |
| −5 | K030984 | Safe Cross Angled Support 0.14, Safe Cross Straight Support Catheter 0.14… | Intra Luminal Therapeutics, Inc. | 2003 | — |
| −4 | K032660 | Xtrak Support Catheter | Xtrak Medical, Inc. | 2003 | — |
| −3 | K051772 | Asahi Tornus Support Catheter | Asahi Intecc Co., Ltd. | 2005 | — |
| −2 | K070372 | Gopher 2F Support Catheter, Model 5600 and Gopher 3F Support Catheter, Model… | Vascular Solutions, Inc. | 2007 | — |
| −1 | K091345 | Gopher Gold Catheter, Model 5620 | Vascular Solutions, Inc. | 2009 | — |
| 0 (this device) | K101479 | Wingman Extendable Tip Support Catheter | Reflow Medical | 2010 | — |
| +1 | K120178 | Wingman Extendable Tip Support Catheter | Reflow Medical | 2012 | — |
| +2 | K132420 | Wingman Extendable Tip Support Catheter | Reflow Medical | 2013 | — |
| +3 | K141547 | Wingman Extendable Tip Support Catheter | Reflow Medical | 2014 | Class I |
| +4 | K173661 | Wingman 35 Crossing Catheter | Reflow Medical, Inc. | 2018 | — |
| +3 | K151880 | Wingman Crossing Catheter | Reflow Medical | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 1 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 1 |
| 2015 | 1 | 0 |
| 2018 | 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.
2 devices in this family have 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 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? (3)
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 Catheter | 2001 |
| * | K072750 | Spectranetics Quick-Cross SUPPORT2 Catheters, Models 518-065 and 518-066Summary page 1…50 CLASSIFICATION: PRODUCT CODE DQY PREDICATE DEVICES: Outback Catheter (KOOI1 577) QuickCross Support Catheter (K 072750) Gopher Support Catheter (K09 1345) Substantially Equivalent To: The Wingman Extendable Tip Suppor… | 2007 |
| * | K091345 | Gopher Gold Catheter, Model 5620Summary page 1…ICATE DEVICES: Outback Catheter (KOOI1 577) QuickCross Support Catheter (K 072750) Gopher Support Catheter (K09 1345) Substantially Equivalent To: The Wingman Extendable Tip Support Catheter is substantially equivalent in intended use, princip… | 2009 |
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 |
|---|---|---|---|
| K120178 | Wingman Extendable Tip Support Catheter | 2012 | 4 |
Has anything in its family been recalled? (2 Class I)
No FDA recall names this device.
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.
- K060327Vascular Solutions Twin-Pass Dual Access Catheter and Skyway Support CatheterVascular Solutions, Inc. · 2006 · 3 generations back · ◆ in the 2006 ancestors bar of FIG. 11 Class I recall
- K141547Wingman Extendable Tip Support CatheterReflow Medical · 2014 · 3 generations on · ◆ in the 2014 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 10 years and passes through 5 companies; a new generation was cleared every 1.6 years on median.
- 2 of the 18 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K120178 (Reflow Medical, 2012) has gone furthest, with 4 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. 2010, this device’s year, is highlighted.
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 Wingman Extendable Tip Support Catheter is intended to be used in conjunction with steerable guidewires to access discreet regions of the peripheral vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices and provide a conduit for the delivery of saline solutions or diagnostic/therapeutic agents.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101479 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101479: Wingman Extendable Tip Support Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101479
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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