510(k) · Cleared
Recalled · Class II · 2013Softouch Diagnostic Intravascular Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mallinckrodt Medical · DQO Catheter, Intravascular, Diagnostic
Cleared on Nov 15, 1994 after a 105-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 5 of the 23 devices in its family, counting itself, have a Class I recall. 22 later devices descend from it. It has been recalled 4 times.
- Decided
- Nov 15, 1994
- Review
- 105 days
- Class
- Class II
- Product code
- DQO
- Recalls
- 4
- Predicates
- 0
22 later devices descend from it, 5 citing it directly. 5 of the 23 devices in this family, counting this one, have a Class I recall.
- This deviceK943739 Softouch Diagnostic Intravascular CatheterMallinckrodt Medical · 1994
- Descendant · cites it directly · 15 of its ownK050168 Langston Dual Lumen Pressure Monitoring CatheterVascular Solutions, Inc. · 2005
- Descendant · cites it directly · 8 of its ownK051395 Langston Dual Lumen Pressure Monitoring CatheterVascular Solutions, Inc. · 2005 · Recalled (Class I)
- Descendant · 2 generations on · 7 of its ownK063723 Impella Recover LP 2.5 Percutaneous Cardiac Support SystemAbiomed, Inc. · 2008
- Descendant · cites it directly · 7 of its ownK041909 Vascular Solutions Langston Dual Lumen Pigtail Catheter (DLP)Vascular Solutions, Inc. · 2004
- Descendant · 2 generations on · 6 of its ownK061565 Langston Dual Lumen CatheterVascular Solutions, Inc. · 2006 · Recalled (Class I)
Showing 5 of 22 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 22 · See all- K050168Langston Dual Lumen Pressure Monitoring CatheterVascular Solutions, Inc. · 2005 · cites it directly15descendants
- K051395Langston Dual Lumen Pressure Monitoring CatheterVascular Solutions, Inc. · 2005 · cites it directly8descendants
- K063723Impella Recover LP 2.5 Percutaneous Cardiac Support SystemAbiomed, Inc. · 2008 · 2 generations on7descendants
- K041909Vascular Solutions Langston Dual Lumen Pigtail Catheter (DLP)Vascular Solutions, Inc. · 2004 · cites it directly7descendants
- K061565Langston Dual Lumen CatheterVascular Solutions, Inc. · 2006 · 2 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K943739 | Softouch Diagnostic Intravascular Catheter | Mallinckrodt Medical | 1994 | — |
| +1 | K050168 | Langston Dual Lumen Pressure Monitoring Catheter | Vascular Solutions, Inc. | 2005 | — |
| +1 | K051395 | Langston Dual Lumen Pressure Monitoring Catheter | Vascular Solutions, Inc. | 2005 | Class I |
| +2 | K063723 | Impella Recover LP 2.5 Percutaneous Cardiac Support System | Abiomed, Inc. | 2008 | — |
| +1 | K041909 | Vascular Solutions Langston Dual Lumen Pigtail Catheter (DLP) | Vascular Solutions, Inc. | 2004 | — |
| +2 | K061565 | Langston Dual Lumen Catheter | Vascular Solutions, Inc. | 2006 | Class I |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 2 | 1 |
| 2006 | 1 | 1 |
| 2007 | 2 | 1 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 1 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 1 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
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.
5 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (22)
See all 225 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K050168 | Langston Dual Lumen Pressure Monitoring Catheter | 2005 | 15 |
| K051395 | Langston Dual Lumen Pressure Monitoring Catheter Class I | 2005 | 8 |
| K041909 | Vascular Solutions Langston Dual Lumen Pigtail Catheter (DLP) | 2004 | 7 |
| K113819 | Mongoose Angiographic Catheter | 2012 | 1 |
| K143604 | Alvision Interventional Cardiology Diagnostic Catheter, Alvicath Endovascular Diagnostic… | 2015 | 0 |
Has anything in its family been recalled? (5 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 13, 2013 | Class II | Z-0045-2014 | Process control | 4 lots of Performa Cardiac Multipacks contain a JR4.0 catheter with a slight variation in tip shape. |
| May 2, 2013 | Class II | Z-1408-2013 | Process control | Merit Medical Systems is recalling various lots of Performa Cardiac Multipacks containing a JR4.0 catheter due to a slight variation in tip shape. |
| Nov 5, 2003 | Not classified | Z-0159-04 | Other | Angiographic catheter tips may separate during use. |
| Nov 5, 2003 | Not classified | Z-0158-04 | Other | Angiographic catheter tips may separate during use. |
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 · Cites it directly · ◆ in the 2005 descendants bar of FIG. 15 Class I recalls
- K061565Langston Dual Lumen CatheterVascular Solutions, Inc. · 2006 · 2 generations on · ◆ in the 2006 descendants bar of FIG. 11 Class I recall
- K062877Twin-Pass .023 Dual Access Catheter, Model 5230Vascular Solutions, Inc. · 2007 · 3 generations on · ◆ in the 2007 descendants bar of FIG. 11 Class I recall
- K102726Cardiohelp SystemMaquet Cardiopulmonary, AG · 2011 · 4 generations on · ◆ in the 2011 descendants bar of FIG. 11 Class I recall
- K133598Cardiohelp SystemMaquet Cardiopulmonary, AG · 2014 · 5 generations on · ◆ in the 2014 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K050168 (Vascular Solutions, Inc., 2005) has gone furthest, with 15 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) | — |
https://510kreport.com/device/K943739 · printed Nov 6, 2026
Cite this page
510(k) Report. “K943739: Softouch Diagnostic Intravascular Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K943739
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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