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, Ltd. · DQO Catheter, Intravascular, Diagnostic
Cleared on Oct 23, 2020 as substantially equivalent to K173430 (Accurate Medical Therapeutics, Ltd., 2018) after a 30-day review. Its family tree reaches back 4 generations to 1992. 2 later devices descend from it.
- Decided
- Oct 23, 2020
- Review
- 30 days
- Class
- Class II
- Product code
- DQO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K915414 (1992). 2 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK915414 Terumo Angiogtaphic CatheterTerumo Medical Corp. · 1992
- 3 generations backK981359 GT LeggieroTerumo Medical Corp. · 1999
- 2 generations backK033583 ProgreatTerumo Medical Corp. · 2003
- 1 generation backK173430 SeQure® NF and SeQure® MicrocathetersAccurate Medical Therapeutics, Ltd. · 2018
- This deviceK202797 Drakon and Sequre MicrocathetersAccurate Medical Therapeutics, Ltd. · 2020
- Descendant · cites it directly · 1 of its ownK203487 Drakon and Sequre MicrocathetersAccurate Medical Therapeutics, Ltd. · 2020
- Descendant · cites it directly · 0 of its ownK231293 Drakon™ and Sequre® MicrocathetersAccurate Medical Therapeutics · 2023
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K915414 | Terumo Angiogtaphic Catheter | Terumo Medical Corp. | 1992 | — |
| −3 | K981359 | GT Leggiero | Terumo Medical Corp. | 1999 | — |
| −2 | K033583 | Progreat | Terumo Medical Corp. | 2003 | — |
| −1 | K173430 | SeQure® NF and SeQure® Microcatheters | Accurate Medical Therapeutics, Ltd. | 2018 | — |
| 0 (this device) | K202797 | Drakon and Sequre Microcatheters | Accurate Medical Therapeutics, Ltd. | 2020 | — |
| +1 | K203487 | Drakon and Sequre Microcatheters | Accurate Medical Therapeutics, Ltd. | 2020 | — |
| +1 | K231293 | Drakon™ and Sequre® Microcatheters | Accurate Medical Therapeutics | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 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.
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? (1)
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 the Sequre NF and Sequre® microcatheters, cleared under K173430 IV. DEVICE DESCRIPTION The Drakon™ and Sequre® microcatheters are single use microcatheters primarily comprised of a luer lock h… | 2018 |
What descends from it? (2)
2 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?
- The line of descent spans 28 years and passes through 2 companies; a new generation was cleared every 7.0 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K203487 (Accurate Medical Therapeutics, Ltd., 2020) has gone furthest, with 1 descendant of its own.
- 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. 2020, 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K202797 · printed Nov 6, 2026
Cite this page
510(k) Report. “K202797: 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/K202797
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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