510(k) · Cleared
ClearedUsci Cardiovascular Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
C.R. Bard, Inc. · DQO Catheter, Intravascular, Diagnostic
Cleared on Mar 5, 1981 after a 15-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 of the 9 devices in its family, counting itself, have a Class I recall. 8 later devices descend from it.
- Decided
- Mar 5, 1981
- Review
- 15 days
- Class
- Class II
- Product code
- DQO
- Recalls
- None
- Predicates
- 0
8 later devices descend from it, 1 citing it directly. 2 of the 9 devices in this family, counting this one, have a Class I recall.
- This deviceK810412 Usci Cardiovascular CatheterC.R. Bard, Inc. · 1981
- 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)
- Descendant · 3 generations on · 2 of its ownK062627 Innerchange Micro-Introducer Catheter, Models 7900 Through 7905Vascular Solutions, Inc. · 2007
- Descendant · 3 generations on · 1 of its ownK170544 Langston dual lumen catheterVascular Solutions, Inc. · 2017
- Descendant · 4 generations on · 1 of its ownK073585 Innerchange Micro-Introducer Catheter, Models 7900, 7901, 7902…Vascular Solutions, Inc. · 2008
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- 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
- K062627Innerchange Micro-Introducer Catheter, Models 7900 Through 7905Vascular Solutions, Inc. · 2007 · 3 generations on2descendants
- K170544Langston dual lumen catheterVascular Solutions, Inc. · 2017 · 3 generations on1descendant
- K073585Innerchange Micro-Introducer Catheter, Models 7900, 7901, 7902, 7903, 7904 and 7905Vascular Solutions, Inc. · 2008 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K810412 | Usci Cardiovascular Catheter | C.R. Bard, Inc. | 1981 | — |
| +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 |
| +3 | K062627 | Innerchange Micro-Introducer Catheter, Models 7900 Through 7905 | Vascular Solutions, Inc. | 2007 | — |
| +3 | K170544 | Langston dual lumen catheter | Vascular Solutions, Inc. | 2017 | — |
| +4 | K073585 | Innerchange Micro-Introducer Catheter, Models 7900, 7901, 7902, 7903, 7904 and… | Vascular Solutions, Inc. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2006 | 1 | 1 |
| 2007 | 2 | 1 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2017 | 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.
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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (8)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K041909 | Vascular Solutions Langston Dual Lumen Pigtail Catheter (DLP) | 2004 | 7 |
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 · 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
What does this lineage say?
- Of its descendants, K041909 (Vascular Solutions, Inc., 2004) has gone furthest, with 7 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/K810412 · printed Nov 6, 2026
Cite this page
510(k) Report. “K810412: Usci Cardiovascular Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K810412
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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