510(k) · Cleared
ClearedSENDERO Microcatheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Okami Medical, Inc. · DQY Catheter, Percutaneous
Cleared on Mar 8, 2024 as substantially equivalent to K231600 (Okami Medical, Inc., 2023) after a 29-day review. Its family tree reaches back 9 generations to 1996. 1 later device descends from it.
- Decided
- Mar 8, 2024
- Review
- 29 days
- Class
- Class II
- Product code
- DQY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K960806 (1996). 10 ancestors in all, the oldest K925813 (1994). 1 later device descends from it, 1 citing it directly.
- Root · 9 generations backK960806 Turbo TrackerTarget Therapeutics · 1996
- 5 generations between
- 3 generations backK142449 Headway 27 MicrocatheterMicroVention, Inc. · 2015
- 2 generations backK192625 PG Pro MicrocatheterMicroVention, Inc. A TERUMO Group Company · 2019
- 1 generation backK231600 SENDERO MicrocatheterOkami Medical, Inc. · 2023
- This deviceK240384 SENDERO MicrocatheterOkami Medical, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK242644 SENDERO MAX Delivery CatheterOkami Medical, Inc. · 2024
Show all 9 generations
- Root · 9 generations backK960806 Turbo TrackerTarget Therapeutics · 1996
- 8 generations backK994155 Excelsior 1018 MicrocatheterBoston Scientific, Target · 2000
- 7 generations backK013789 Excelsior SL-10 Microcatheter, Models 168581, 168381, 168181, 168189Boston Scientific, Target · 2001 · Recalled
- 6 generations backK083343 Headway 17 MicrocatheterMicroVention, Inc. · 2008
- 5 generations backK093160 Headway 21 Microcatheter, Model: MC212150SMicroVention, Inc. · 2009
- 4 generations backK110813 Headway 27 MicrocatheterMicroVention, Inc. · 2011
- 3 generations backK142449 Headway 27 MicrocatheterMicroVention, Inc. · 2015
- 2 generations backK192625 PG Pro MicrocatheterMicroVention, Inc. A TERUMO Group Company · 2019
- 1 generation backK231600 SENDERO MicrocatheterOkami Medical, Inc. · 2023
- This deviceK240384 SENDERO MicrocatheterOkami Medical, Inc. · 2024
Most influential descendants
Showing 1 of 1 · See all- K242644SENDERO MAX Delivery CatheterOkami Medical, Inc. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K960806 | Turbo Tracker | Target Therapeutics | 1996 | — |
| −8 | K994155 | Excelsior 1018 Microcatheter | Boston Scientific, Target | 2000 | — |
| −7 | K013789 | Excelsior SL-10 Microcatheter, Models 168581, 168381, 168181, 168189 | Boston Scientific, Target | 2001 | 2 |
| −6 | K083343 | Headway 17 Microcatheter | MicroVention, Inc. | 2008 | — |
| −5 | K093160 | Headway 21 Microcatheter, Model: MC212150S | MicroVention, Inc. | 2009 | — |
| −4 | K110813 | Headway 27 Microcatheter | MicroVention, Inc. | 2011 | — |
| −3 | K142449 | Headway 27 Microcatheter | MicroVention, Inc. | 2015 | — |
| −2 | K192625 | PG Pro Microcatheter | MicroVention, Inc. A TERUMO Group Company | 2019 | — |
| −1 | K231600 | SENDERO Microcatheter | Okami Medical, Inc. | 2023 | — |
| 0 (this device) | K240384 | SENDERO Microcatheter | Okami Medical, Inc. | 2024 | — |
| +1 | K242644 | SENDERO MAX Delivery Catheter | Okami Medical, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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 DQY? 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 DQY device
- #1 K234115 APRO 55 Catheterscore 17.5 · 6 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 |
|---|---|---|---|
| * | K231600 | SENDERO MicrocatheterSummary page 4…Microcatheter Classification Name Catheter, Percutaneous Regulation Number 870.1250 Product Code DQY Predicate Device K231600 – SENDERO Microcatheter – Product Code DQY 510 (k) Summary Date March 1, 2024 Device Description Summary The SENDERO Micr… | 2023 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K242644 | SENDERO MAX Delivery Catheter | 2024 | 0 |
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 5 companies; a new generation was cleared every 3.6 years on median.
- 1 of the 10 ancestors has a recall of any class.
- Of its descendants, K242644 (Okami Medical, Inc., 2024) has gone furthest, with 0 descendants of its own.
How does its category compare?
All DQY devicesDQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · DQY
21in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DQY
115in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQY
1in 2025
Class I (10 since 2007) Class II/III not classified
Adverse event reports per year · DQY
3,056in 2025
MAUDE reports naming product code DQY, 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 | 16 | 85 | 6 | 313 |
| 2008 | 31 | 66 | 12 | 496 |
| 2009 | 37 | 73 | 17 | 819 |
| 2010 | 22 | 74 | 32 | 1,293 |
| 2011 | 36 | 71 | 6 | 1,211 |
| 2012 | 30 | 87 | 2 | 1,191 |
| 2013 | 32 | 92 | 36 (1) | 1,352 |
| 2014 | 19 | 127 | 3 | 1,497 |
| 2015 | 27 | 118 | 3 | 2,337 |
| 2016 | 22 | 117 | 22 (7) | 2,252 |
| 2017 | 26 | 113 | 8 | 2,489 |
| 2018 | 25 | 106 | 2 | 2,855 |
| 2019 | 30 | 111 | 1 | 2,902 |
| 2020 | 20 | 120 | 2 | 2,889 |
| 2021 | 18 | 81 | 2 | 3,006 |
| 2022 | 18 | 74 | 0 | 2,643 |
| 2023 | 18 | 114 | 17 | 3,049 |
| 2024 | 16 | 87 | 1 | 3,190 |
| 2025 | 21 | 115 | 1 (1) | 3,056 |
| 2026 | 11 | 30 | 2 (1) | — |
What is it indicated for?
The SENDERO Microcatheter is intended for the peripheral vasculature for the infusion of diagnostic and therapeutic agents.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K240384 · printed Nov 6, 2026
Cite this page
510(k) Report. “K240384: SENDERO Microcatheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K240384
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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