510(k) · Cleared
ClearedDrakon™ and Sequre® Microcatheters
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Accurate Medical Therapeutics · DQO Catheter, Intravascular, Diagnostic
Cleared on Jun 1, 2023 as substantially equivalent to K173430 (Accurate Medical Therapeutics, Ltd., 2018) and 2 other predicates after a 28-day review. Its family tree reaches back 6 generations to 1992.
- Decided
- Jun 1, 2023
- Review
- 28 days
- Class
- Class II
- Product code
- DQO
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K915414 (1992). No later device cites it as a predicate yet.
- Root · 6 generations backK915414 Terumo Angiogtaphic CatheterTerumo Medical Corp. · 1992
- 5 generations backK981359 GT LeggieroTerumo Medical Corp. · 1999
- 4 generations backK033583 ProgreatTerumo Medical Corp. · 2003
- 3 generations backK173430 SeQure® NF and SeQure® MicrocathetersAccurate Medical Therapeutics, Ltd. · 2018
- 2 generations backK202797 Drakon and Sequre MicrocathetersAccurate Medical Therapeutics, Ltd. · 2020
- 1 generation backK203487 Drakon and Sequre MicrocathetersAccurate Medical Therapeutics, Ltd. · 2020
- This deviceK231293 Drakon™ and Sequre® MicrocathetersAccurate Medical Therapeutics · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K915414 | Terumo Angiogtaphic Catheter | Terumo Medical Corp. | 1992 | — |
| −5 | K981359 | GT Leggiero | Terumo Medical Corp. | 1999 | — |
| −4 | K033583 | Progreat | Terumo Medical Corp. | 2003 | — |
| −3 | K173430 | SeQure® NF and SeQure® Microcatheters | Accurate Medical Therapeutics, Ltd. | 2018 | — |
| −2 | K202797 | Drakon and Sequre Microcatheters | Accurate Medical Therapeutics, Ltd. | 2020 | — |
| −1 | K203487 | Drakon and Sequre Microcatheters | Accurate Medical Therapeutics, Ltd. | 2020 | — |
| 0 (this device) | K231293 | Drakon™ and Sequre® Microcatheters | Accurate Medical Therapeutics | 2023 | — |
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.
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? (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 |
|---|---|---|---|
| * | K173430 | SeQure® NF and SeQure® MicrocathetersSummary page 4…DQO III. PREDICATE DEVICE Accurate Medical Therapeutics Ltd. claims substantial equivalence to previous submissions of Drakon™ and Sequre® microcatheters, cleared under K173430, K202797, K203487. IV. DEVICE DESCRIPTION The Drakon™ and Sequre® microcatheters are single use microcatheters primarily compris… | 2018 |
| * | K202797 | Drakon and Sequre MicrocathetersSummary page 4…PREDICATE DEVICE Accurate Medical Therapeutics Ltd. claims substantial equivalence to previous submissions of Drakon™ and Sequre® microcatheters, cleared under K173430, K202797, K203487. IV. DEVICE DESCRIPTION The Drakon™ and Sequre® microcatheters are single use microcatheters primarily comprised of a l… | 2020 |
| * | K203487 | Drakon and Sequre MicrocathetersSummary page 4…E DEVICE Accurate Medical Therapeutics Ltd. claims substantial equivalence to previous submissions of Drakon™ and Sequre® microcatheters, cleared under K173430, K202797, K203487. IV. DEVICE DESCRIPTION The Drakon™ and Sequre® microcatheters are single use microcatheters primarily comprised of a luer lock… | 2020 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 31 years and passes through 3 companies; a new generation was cleared every 4.9 years on median.
- None of the 6 ancestors has a recall.
- 2 other devices also cite its predicate K173430.
How does its category compare?
All DQO devicesDQO Catheter, Intravascular, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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 Drakon™ and SeQure® microcatheters are intended for the infusion of contrast media into all peripheral vessels.
The Drakon™ and SeQure® microcatheters are also intended for drug infusion in intra-arterial therapy and infusion of embolic materials.
The Drakon™ and the SeQure® microcatheters should not be used in cerebral vessels.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K231293 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231293: Drakon™ and Sequre® Microcatheters.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231293
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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