510(k) · Cleared
ClearedLangston 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 Nov 17, 2017 as substantially equivalent to K061565 (Vascular Solutions, Inc., 2006) and 1 other predicate after a 266-day review. Its family tree reaches back 3 generations to 1981. 2 of the 9 devices in its family, counting itself, have a Class I recall. 1 later device descends from it.
- Decided
- Nov 17, 2017
- Review
- 266 days
- Class
- Class II
- Product code
- DQO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K810412 (1981). 7 ancestors in all. 1 later device descends from it, 1 citing it directly. 2 of the 9 devices in this family, counting this one, have a Class I recall.
- Root · 3 generations backK810412 Usci Cardiovascular CatheterC.R. Bard, Inc. · 1981
- 2 generations backK041909 Vascular Solutions Langston Dual Lumen Pigtail Catheter (DLP)Vascular Solutions, Inc. · 2004
- 1 generation backK061565 Langston Dual Lumen CatheterVascular Solutions, Inc. · 2006 · Recalled (Class I)
- This deviceK170544 Langston dual lumen catheterVascular Solutions, Inc. · 2017
- Descendant · cites it directly · 0 of its ownK222023 RayFlowHexacath · 2023
Class I recalls in this family
Most influential descendants
Showing 1 of 1 · See all- K222023RayFlowHexacath · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K810412 | Usci Cardiovascular Catheter | C.R. Bard, Inc. | 1981 | — |
| −2 | K041909 | Vascular Solutions Langston Dual Lumen Pigtail Catheter (DLP) | Vascular Solutions, Inc. | 2004 | — |
| −1 | K061565 | Langston Dual Lumen Catheter | Vascular Solutions, Inc. | 2006 | Class I |
| 0 (this device) | K170544 | Langston dual lumen catheter | Vascular Solutions, Inc. | 2017 | — |
| +1 | K222023 | RayFlow | Hexacath | 2023 | — |
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 |
|---|---|---|
| 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.
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 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? (2)
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 |
|---|---|---|---|
| * | K061565 | Langston Dual Lumen CatheterSummary page 4…ic intravascular catheter Classification Product Code DQO Classification Name 21 CFR 870.1200 Diagnostic intravascular catheter Predicate Devices K061565, Langston dual lumen catheter, Vascular Solutions, Inc. K051395, Langston dual lumen catheter, Vasc… | 2006 |
| * | K051395 | Langston Dual Lumen Pressure Monitoring CatheterSummary page 4…FR 870.1200 Diagnostic intravascular catheter Predicate Devices K061565, Langston dual lumen catheter, Vascular Solutions, Inc. K051395, Langston dual lumen catheter, Vascular Solutions, Inc. K170544 Device Models… | 2005 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K222023 | RayFlow | 2023 | 0 |
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.
- K061565Langston Dual Lumen CatheterVascular Solutions, Inc. · 2006 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
- K051395Langston Dual Lumen Pressure Monitoring CatheterVascular Solutions, Inc. · 2005 · Direct predicate · ◆ in the 2005 ancestors bar of FIG. 15 Class I recalls
What does this lineage say?
- The line of descent spans 36 years and passes through 2 companies; a new generation was cleared every 11.3 years on median.
- 3 of the 7 ancestors have a recall of any class; 2 have a Class I recall.
- Of its descendants, K222023 (Hexacath, 2023) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K061565.
How does its category compare?
All DQO devicesDQO Catheter, Intravascular, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
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 Langston 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/K170544 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170544: Langston dual lumen catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170544
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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