510(k) · Cleared
ClearedAngiographic Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Target Therapeutics · DQO Catheter, Intravascular, Diagnostic
Cleared on Aug 16, 1993 after a 248-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 58 later devices descend from it.
- Decided
- Aug 16, 1993
- Review
- 248 days
- Class
- Class II
- Product code
- DQO
- Recalls
- None
- Predicates
- 0
58 later devices descend from it, 3 citing it directly.
- This deviceK926243 Angiographic CatheterTarget Therapeutics · 1993
- Descendant · cites it directly · 50 of its ownK030637 Ekos Peripheral Infusion SystemEkos Corp. · 2003
- Descendant · 2 generations on · 46 of its ownK033214 Ekos Peripheral Infusion SystemEkos Corp. · 2003
- Descendant · 3 generations on · 39 of its ownK041629 Lysus Infusion SystemEkos Corp. · 2004
- Descendant · 4 generations on · 38 of its ownK042456 Lysus Infusion SystemEkos Corp. · 2004 · Recalled
- Descendant · 5 generations on · 35 of its ownK051319 Lysus Infusion SystemEkos Corp. · 2005
Showing 5 of 58 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 58 · See all- K030637Ekos Peripheral Infusion SystemEkos Corp. · 2003 · cites it directly50descendants
- K033214Ekos Peripheral Infusion SystemEkos Corp. · 2003 · 2 generations on46descendants
- K041629Lysus Infusion SystemEkos Corp. · 2004 · 3 generations on39descendants
- K042456Lysus Infusion SystemEkos Corp. · 2004 · 4 generations on38descendants
- K051319Lysus Infusion SystemEkos Corp. · 2005 · 5 generations on35descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K926243 | Angiographic Catheter | Target Therapeutics | 1993 | — |
| +1 | K030637 | Ekos Peripheral Infusion System | Ekos Corp. | 2003 | — |
| +2 | K033214 | Ekos Peripheral Infusion System | Ekos Corp. | 2003 | — |
| +3 | K041629 | Lysus Infusion System | Ekos Corp. | 2004 | — |
| +4 | K042456 | Lysus Infusion System | Ekos Corp. | 2004 | 3 |
| +5 | K051319 | Lysus Infusion System | Ekos Corp. | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 4 | 0 |
| 2005 | 7 | 0 |
| 2006 | 5 | 0 |
| 2007 | 4 | 0 |
| 2008 | 7 | 0 |
| 2009 | 1 | 0 |
| 2011 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2018 | 3 | 0 |
| 2019 | 4 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2024 | 4 | 0 |
| 2025 | 1 | 0 |
| 2026 | 4 | 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.
Planning a device in DQO? 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? (58)
See all 583 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K030637 (Ekos Corp., 2003) has gone furthest, with 50 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/K926243 · printed Nov 5, 2026
Cite this page
510(k) Report. “K926243: Angiographic Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K926243
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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