510(k) · Cleared
Recalled · Class I · 2020Langston Dual Lumen Pressure Monitoring 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 Jun 24, 2005 as substantially equivalent to K943739 (Mallinckrodt Medical, 1994) after a 28-day review. Its family tree reaches back 1 generation to 1994. 3 of the 10 devices in its family, counting itself, have a Class I recall. 8 later devices descend from it. It has been recalled 6 times, including 5 Class I recalls.
- Decided
- Jun 24, 2005
- Review
- 28 days
- Class
- Class II
- Product code
- DQO
- Recalls
- 6 (5 Class I)
- Predicates
- 1
Its longest line of descent runs back 1 generation to K943739 (1994). 8 later devices descend from it, 3 citing it directly. 3 of the 10 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK943739 Softouch Diagnostic Intravascular CatheterMallinckrodt Medical · 1994 · Recalled
- This deviceK051395 Langston Dual Lumen Pressure Monitoring CatheterVascular Solutions, Inc. · 2005
- Descendant · cites it directly · 6 of its ownK061565 Langston Dual Lumen CatheterVascular Solutions, Inc. · 2006 · Recalled (Class I)
- Descendant · 2 generations on · 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 · 3 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
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 8 · See all- K061565Langston Dual Lumen CatheterVascular Solutions, Inc. · 2006 · cites it directly6descendants
- K062627Innerchange Micro-Introducer Catheter, Models 7900 Through 7905Vascular Solutions, Inc. · 2007 · 2 generations on2descendants
- 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 · 3 generations on1descendant
- K222023RayFlowHexacath · 2023 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K943739 | Softouch Diagnostic Intravascular Catheter | Mallinckrodt Medical | 1994 | 4 |
| 0 (this device) | K051395 | Langston Dual Lumen Pressure Monitoring Catheter | Vascular Solutions, Inc. | 2005 | — |
| +1 | K061565 | Langston Dual Lumen Catheter | Vascular Solutions, Inc. | 2006 | Class I |
| +2 | K062627 | Innerchange Micro-Introducer Catheter, Models 7900 Through 7905 | Vascular Solutions, Inc. | 2007 | — |
| +1 | K170544 | Langston dual lumen catheter | Vascular Solutions, Inc. | 2017 | — |
| +3 | K073585 | Innerchange Micro-Introducer Catheter, Models 7900, 7901, 7902, 7903, 7904 and… | Vascular Solutions, Inc. | 2008 | — |
| +2 | K222023 | RayFlow | Hexacath | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 1 |
| 2007 | 2 | 1 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2017 | 1 | 0 |
| 2022 | 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 |
|---|---|---|---|
| * | K943739 | Softouch Diagnostic Intravascular CatheterSummary page 1…ement catheter and for delivery of contrast media during angiographic studies. The DLP catheter consists of the Merit Medical Softouch Diagnostic Intravascular Catheter (K943739) as the inner lumen and an extruded outer lumen designed by Vascular Solutions. The inner lumen and hub assembly are purchased fr… | 1994 |
| * | — | Langston Dual Lumen Pigtail Catheters Named without a submission number | |
| * | — | Cordis Dual Lumen Pressure Monitoring Catheter Named without a submission number |
What descends from it? (8)
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-0111-2021 | Process control | The inner lumen of the Langston catheter may separate from the hub during pressure injection. |
| Aug 31, 2020 | Class I | Z-0112-2021 | Process control | The inner lumen of the Langston catheter may separate from the hub during pressure injection. |
| Aug 31, 2020 | Class I | Z-0110-2021 | Process control | The inner lumen of the Langston catheter may separate from the hub during pressure injection. |
| Mar 16, 2020 | Class I | Z-1747-2020 | Process control | The inner lumen of the Langston catheter may separate from the hub during pressure injection. |
| May 27, 2014 | Class I | Z-1981-2014 | Component design/selection | The inner catheter of some Langston V2 Dual Lumen Catheters have separated from the device hub during contrast pressure injections. This may require an intervention to retrieve the separated piece from the patient to prevent injury. |
| Sep 2, 2010 | Not classified | Z-2608-2010 | Process control | Investigation of a recent Device Experience Report has made us aware of a potential problem with our 6F Langston dual lumen pigtail catheter (Model 5540) with the following lot numbers: 548110, 548227, 548364, 548430, 548554 & 548723.… |
The 5 latest of 6 recalls; the web page lists all.
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.
- K061565Langston Dual Lumen CatheterVascular Solutions, Inc. · 2006 · Cites it directly · ◆ in the 2006 descendants bar of FIG. 11 Class I recall
- K062877Twin-Pass .023 Dual Access Catheter, Model 5230Vascular Solutions, Inc. · 2007 · 2 generations on · ◆ in the 2007 descendants bar of FIG. 11 Class I recall
What does this lineage say?
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 Vascular Solutions Langston TM Dual Lumen Pressure Monitoring 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/K051395 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051395: Langston Dual Lumen Pressure Monitoring Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051395
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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