510(k) · Cleared
ClearedSENDERO MAX Delivery Catheter
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 Dec 20, 2024 as substantially equivalent to K240384 (Okami Medical, Inc., 2024) after a 108-day review. Its family tree reaches back 10 generations to 1996.
- Decided
- Dec 20, 2024
- Review
- 108 days
- Class
- Class II
- Product code
- DQY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K960806 (1996). 11 ancestors in all, the oldest K925813 (1994). No later device cites it as a predicate yet.
- Root · 10 generations backK960806 Turbo TrackerTarget Therapeutics · 1996
- 6 generations between
- 3 generations backK192625 PG Pro MicrocatheterMicroVention, Inc. A TERUMO Group Company · 2019
- 2 generations backK231600 SENDERO MicrocatheterOkami Medical, Inc. · 2023
- 1 generation backK240384 SENDERO MicrocatheterOkami Medical, Inc. · 2024
- This deviceK242644 SENDERO MAX Delivery CatheterOkami Medical, Inc. · 2024
Show all 10 generations
- Root · 10 generations backK960806 Turbo TrackerTarget Therapeutics · 1996
- 9 generations backK994155 Excelsior 1018 MicrocatheterBoston Scientific, Target · 2000
- 8 generations backK013789 Excelsior SL-10 Microcatheter, Models 168581, 168381, 168181, 168189Boston Scientific, Target · 2001 · Recalled
- 7 generations backK083343 Headway 17 MicrocatheterMicroVention, Inc. · 2008
- 6 generations backK093160 Headway 21 Microcatheter, Model: MC212150SMicroVention, Inc. · 2009
- 5 generations backK110813 Headway 27 MicrocatheterMicroVention, Inc. · 2011
- 4 generations backK142449 Headway 27 MicrocatheterMicroVention, Inc. · 2015
- 3 generations backK192625 PG Pro MicrocatheterMicroVention, Inc. A TERUMO Group Company · 2019
- 2 generations backK231600 SENDERO MicrocatheterOkami Medical, Inc. · 2023
- 1 generation backK240384 SENDERO MicrocatheterOkami Medical, Inc. · 2024
- This deviceK242644 SENDERO MAX Delivery CatheterOkami Medical, Inc. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K960806 | Turbo Tracker | Target Therapeutics | 1996 | — |
| −9 | K994155 | Excelsior 1018 Microcatheter | Boston Scientific, Target | 2000 | — |
| −8 | K013789 | Excelsior SL-10 Microcatheter, Models 168581, 168381, 168181, 168189 | Boston Scientific, Target | 2001 | 2 |
| −7 | K083343 | Headway 17 Microcatheter | MicroVention, Inc. | 2008 | — |
| −6 | K093160 | Headway 21 Microcatheter, Model: MC212150S | MicroVention, Inc. | 2009 | — |
| −5 | K110813 | Headway 27 Microcatheter | MicroVention, Inc. | 2011 | — |
| −4 | K142449 | Headway 27 Microcatheter | MicroVention, Inc. | 2015 | — |
| −3 | K192625 | PG Pro Microcatheter | MicroVention, Inc. A TERUMO Group Company | 2019 | — |
| −2 | K231600 | SENDERO Microcatheter | Okami Medical, Inc. | 2023 | — |
| −1 | K240384 | SENDERO Microcatheter | Okami Medical, Inc. | 2024 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K240384 | SENDERO MicrocatheterSummary page 5…Catheter Classification Name Catheter, Percutaneous Regulation Number 870.1250 Product Code DQY Predicate Device K240384 – SENDERO Microcatheter – Product Code DQY Reference Device K140080 – Envoy Distal Access Guiding Catheter – Product C… | 2024 |
| † | K140080 | Envoy Distal Access (DA) Guiding Catheter, 6F, 95CM & 105CM, Straight & XB, MPD & XB… | 2014 |
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 28 years and passes through 5 companies; a new generation was cleared every 3.6 years on median.
- 1 of the 11 ancestors has a recall of any class.
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 MAX Delivery Catheter 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/K242644 · printed Nov 6, 2026
Cite this page
510(k) Report. “K242644: SENDERO MAX Delivery Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K242644
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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