510(k) · Cleared
ClearedCerusEndo Microcatheter (027)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cerus Endovascular, Inc. · QJP Catheter, Percutaneous, Neurovasculature
Cleared on Mar 15, 2022 as substantially equivalent to K142449 (MicroVention, Inc., 2015) after a 162-day review. Its family tree reaches back 7 generations to 1996.
- Decided
- Mar 15, 2022
- Review
- 162 days
- Class
- Class II
- Product code
- QJP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K960806 (1996). 8 ancestors in all, the oldest K925813 (1994). No later device cites it as a predicate yet.
- Root · 7 generations backK960806 Turbo TrackerTarget Therapeutics · 1996
- 6 generations backK994155 Excelsior 1018 MicrocatheterBoston Scientific, Target · 2000
- 5 generations backK013789 Excelsior SL-10 Microcatheter, Models 168581, 168381, 168181, 168189Boston Scientific, Target · 2001 · Recalled
- 4 generations backK083343 Headway 17 MicrocatheterMicroVention, Inc. · 2008
- 3 generations backK093160 Headway 21 Microcatheter, Model: MC212150SMicroVention, Inc. · 2009
- 2 generations backK110813 Headway 27 MicrocatheterMicroVention, Inc. · 2011
- 1 generation backK142449 Headway 27 MicrocatheterMicroVention, Inc. · 2015
- This deviceK213314 CerusEndo Microcatheter (027)Cerus Endovascular, Inc. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K960806 | Turbo Tracker | Target Therapeutics | 1996 | — |
| −6 | K994155 | Excelsior 1018 Microcatheter | Boston Scientific, Target | 2000 | — |
| −5 | K013789 | Excelsior SL-10 Microcatheter, Models 168581, 168381, 168181, 168189 | Boston Scientific, Target | 2001 | 2 |
| −4 | K083343 | Headway 17 Microcatheter | MicroVention, Inc. | 2008 | — |
| −3 | K093160 | Headway 21 Microcatheter, Model: MC212150S | MicroVention, Inc. | 2009 | — |
| −2 | K110813 | Headway 27 Microcatheter | MicroVention, Inc. | 2011 | — |
| −1 | K142449 | Headway 27 Microcatheter | MicroVention, Inc. | 2015 | — |
| 0 (this device) | K213314 | CerusEndo Microcatheter (027) | Cerus Endovascular, Inc. | 2022 | — |
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 QJP? 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 QJP device
- #1 K212838 Benchmark Intracranial Access Systemscore 16.9 · 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 |
|---|---|---|---|
| * | K142449 | Headway 27 MicrocatheterSummary page 4…me: Percutaneous Catheter 21 CFR 870.1250 Regulatory Class: Class II Product Code: QJP III. PREDICATE DEVICE K142449: Headway 27 Microcatheter manufactured by MicroVention Inc. The predicate device has not been subject to a design-related… | 2015 |
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 26 years and passes through 4 companies; a new generation was cleared every 3.6 years on median.
- 1 of the 8 ancestors has a recall of any class.
- 1 other device also cites its predicate K142449.
How does its category compare?
All QJP devicesQJP Catheter, Percutaneous, Neurovasculature: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · QJP
22so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · QJP
116in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QJP
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · QJP
688in 2025
MAUDE reports naming product code QJP, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 9 | 72 | 0 | 16 |
| 2021 | 12 | 139 | 0 | 29 |
| 2022 | 14 | 206 | 0 | 30 |
| 2023 | 14 | 184 | 0 | 75 |
| 2024 | 18 | 188 | 1 | 130 |
| 2025 | 14 | 116 | 0 | 688 |
| 2026 | 22 | 141 | 0 | — |
What is it indicated for?
The CerusEndo Microcatheter (027) is intended to deliver therapeutic devices within the neurovasculature.
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/K213314 · printed Nov 4, 2026
Cite this page
510(k) Report. “K213314: CerusEndo Microcatheter (027).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K213314
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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