510(k) · Cleared
Recalled · Class I · 2020Langston Dual Lumen Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vascular Solutions, Inc. · DQO Catheter, Intravascular, Diagnostic
Cleared on Aug 2, 2006 as substantially equivalent to K041909 (Vascular Solutions, Inc., 2004) and 2 other predicates after a 58-day review. Its family tree reaches back 2 generations to 1981. 3 of the 13 devices in its family, counting itself, have a Class I recall. 6 later devices descend from it. It has been recalled 2 times, including a Class I recall.
- Decided
- Aug 2, 2006
- Review
- 58 days
- Class
- Class II
- Product code
- DQO
- Recalls
- 2 (1 Class I)
- Predicates
- 3
Its longest line of descent runs back 2 generations to K810412 (1981). 6 ancestors in all. 6 later devices descend from it, 3 citing it directly. 3 of the 13 devices in this family, counting this one, have a Class I recall.
- Root · 2 generations backK810412 Usci Cardiovascular CatheterC.R. Bard, Inc. · 1981
- 1 generation backK041909 Vascular Solutions Langston Dual Lumen Pigtail Catheter (DLP)Vascular Solutions, Inc. · 2004
- This deviceK061565 Langston Dual Lumen CatheterVascular Solutions, Inc. · 2006
- Descendant · cites it directly · 2 of its ownK062627 Innerchange Micro-Introducer Catheter, Models 7900 Through 7905Vascular Solutions, Inc. · 2007
- Descendant · cites it directly · 1 of its ownK170544 Langston dual lumen catheterVascular Solutions, Inc. · 2017
- Descendant · 2 generations on · 1 of its ownK073585 Innerchange Micro-Introducer Catheter, Models 7900, 7901, 7902…Vascular Solutions, Inc. · 2008
- Descendant · 2 generations on · 0 of its ownK222023 RayFlowHexacath · 2023
- Descendant · 3 generations on · 0 of its ownK081846 Grebset Micro-Introducer Kit, Models 7950, 7951Vascular Solutions, Inc. · 2009 · Recalled
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 6 · See all- K062627Innerchange Micro-Introducer Catheter, Models 7900 Through 7905Vascular Solutions, Inc. · 2007 · cites it directly2descendants
- K170544Langston dual lumen catheterVascular Solutions, Inc. · 2017 · cites it directly1descendant
- K073585Innerchange Micro-Introducer Catheter, Models 7900, 7901, 7902, 7903, 7904 and 7905Vascular Solutions, Inc. · 2008 · 2 generations on1descendant
- K222023RayFlowHexacath · 2023 · 2 generations on0descendants
- K081846Grebset Micro-Introducer Kit, Models 7950, 7951Vascular Solutions, Inc. · 2009 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K810412 | Usci Cardiovascular Catheter | C.R. Bard, Inc. | 1981 | — |
| −1 | K041909 | Vascular Solutions Langston Dual Lumen Pigtail Catheter (DLP) | Vascular Solutions, Inc. | 2004 | — |
| 0 (this device) | K061565 | Langston Dual Lumen Catheter | Vascular Solutions, Inc. | 2006 | — |
| +1 | K062627 | Innerchange Micro-Introducer Catheter, Models 7900 Through 7905 | Vascular Solutions, Inc. | 2007 | — |
| +1 | K170544 | Langston dual lumen catheter | Vascular Solutions, Inc. | 2017 | — |
| +2 | K073585 | Innerchange Micro-Introducer Catheter, Models 7900, 7901, 7902, 7903, 7904 and… | Vascular Solutions, Inc. | 2008 | — |
| +2 | K222023 | RayFlow | Hexacath | 2023 | — |
| +3 | K081846 | Grebset Micro-Introducer Kit, Models 7950, 7951 | Vascular Solutions, Inc. | 2009 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1994 | 1 | 0 |
| 2005 | 2 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 2 | 1 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2017 | 1 | 0 |
| 2023 | 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.
3 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 DQO device
- #1 K254278 Arterial Pressure Monitoring Set/Trayscore 14.4 · 2 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 |
|---|---|---|---|
| * | K041909 | Vascular Solutions Langston Dual Lumen Pigtail Catheter (DLP)Summary page 1…nfirmed the suitability of the device for its intended use. Predicate Devices: The Langston 7F/5F dual lumen catheter is substantially equivalent to the Langston 8F/5F (K041909), 7F/4F (K050168), and 6F/4F (K051395) dual lumen catheters. Conclusions: The Langston 7F outer lumen and 5F inner lumen is subs… | 2004 |
| * | K050168 | Langston Dual Lumen Pressure Monitoring CatheterSummary page 1…bility of the device for its intended use. Predicate Devices: The Langston 7F/5F dual lumen catheter is substantially equivalent to the Langston 8F/5F (K041909), 7F/4F (K050168), and 6F/4F (K051395) dual lumen catheters. Conclusions: The Langston 7F outer lumen and 5F inner lumen is substantially equival… | 2005 |
| * | K051395 | Langston Dual Lumen Pressure Monitoring CatheterSummary page 1…for its intended use. Predicate Devices: The Langston 7F/5F dual lumen catheter is substantially equivalent to the Langston 8F/5F (K041909), 7F/4F (K050168), and 6F/4F (K051395) dual lumen catheters. Conclusions: The Langston 7F outer lumen and 5F inner lumen is substantially equivalent to the currently… | 2005 |
What descends from it? (6)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (3 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 31, 2020 | Class I | Z-0113-2021 | Process control | The inner lumen of the Langston catheter may separate from the hub during pressure injection. |
| Jun 9, 2011 | Not classified | Z-2770-2011 | Packaging process control | Vascular Solutions, Inc investigation of a recent Device Experience Report has made them aware of a potential problem with their 7F Langston dual lumen pigtail catheter (Model 5515) with lot number 548264. Recently it was reported that… |
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.
- K051395Langston Dual Lumen Pressure Monitoring CatheterVascular Solutions, Inc. · 2005 · Direct predicate · ◆ in the 2005 ancestors bar of FIG. 15 Class I recalls
- K062877Twin-Pass .023 Dual Access Catheter, Model 5230Vascular Solutions, Inc. · 2007 · Cites it directly · ◆ in the 2007 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 25 years and passes through 2 companies; a new generation was cleared every 23.6 years on median.
- 2 of the 6 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K062627 (Vascular Solutions, Inc., 2007) has gone furthest, with 2 descendants of its own.
How does its category compare?
All DQO devicesDQO Catheter, Intravascular, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DQO
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DQO
148in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQO
1in 2023
Class I (11 since 2007) Class II/III not classified
Adverse event reports per year · DQO
656in 2025
MAUDE reports naming product code DQO, 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 | 8 | 106 | 14 | 564 |
| 2008 | 3 | 80 | 4 | 726 |
| 2009 | 8 | 58 | 7 | 933 |
| 2010 | 7 | 137 | 11 | 556 |
| 2011 | 6 | 74 | 7 | 625 |
| 2012 | 15 | 94 | 2 | 532 |
| 2013 | 2 | — | 1 | 753 |
| 2014 | 3 | 109 | 0 | 601 |
| 2015 | 10 | 209 | 1 (1) | 628 |
| 2016 | 4 | 89 | 2 (1) | 614 |
| 2017 | 10 | 176 | 1 | 873 |
| 2018 | 10 | 234 | 2 | 777 |
| 2019 | 6 | 113 | 71 | 386 |
| 2020 | 3 | 30 | 4 (4) | 312 |
| 2021 | 1 | — | 0 | 338 |
| 2022 | 4 | 181 | 1 | 379 |
| 2023 | 4 | 73 | 1 (1) | 391 |
| 2024 | 4 | 148 | 0 | 511 |
| 2025 | 2 | — | 0 | 656 |
| 2026 | 3 | 85 | 24 (4) | — |
What is it indicated for?
The LangstonTM Dual Lumen Catheter is indicated for delivery of contrast medium in angiographic studies and for simultaneous pressure measurement from two sites. This type of pressure measurement is useful in determining transvalvular, intravascular and intraventricular pressure gradients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061565 · printed Nov 5, 2026
Cite this page
510(k) Report. “K061565: Langston Dual Lumen Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K061565
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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