510(k) · Cleared
ClearedExcipio LV Prime Thrombectomy Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Contego Medical, Inc. · QEW Peripheral Mechanical Thrombectomy With Aspiration
Cleared on Jun 13, 2025 as substantially equivalent to K223897 (Contego Medical, Inc., 2023) after a 30-day review. Its family tree reaches back 7 generations to 2018. 3 of the 26 devices in its family, counting itself, have a Class I recall.
- Decided
- Jun 13, 2025
- Review
- 30 days
- Class
- Class II
- Product code
- QEW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K183198 (2018). 25 ancestors in all, the oldest K832023 (1983). No later device cites it as a predicate yet. 3 of the 26 devices in this family, counting this one, have a Class I recall.
- Root · 7 generations backK183198 FlowTriever Retrieval/Aspiration SystemInari Medical · 2018
- 6 generations backK191368 FlowTriever Retrieval/Aspiration SystemInari Medical · 2019
- 5 generations backK191710 FlowTriever Retrieval/Aspiration SystemInari Medical · 2019
- 4 generations backK202345 FlowTriever Retrieval/Aspiration SystemInari Medical · 2020
- 3 generations backK211013 FlowTriever Retrieval/Aspiration System, FlowTriever Catheters…Inari Medical, Inc. · 2021
- 2 generations backK213402 Triever24, Triever20Inari Medical · 2022
- 1 generation backK223897 Excipio LV Thrombectomy DeviceContego Medical, Inc. · 2023
- This deviceK251485 Excipio LV Prime Thrombectomy DeviceContego Medical, Inc. · 2025
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K183198 | FlowTriever Retrieval/Aspiration System | Inari Medical | 2018 | — |
| −6 | K191368 | FlowTriever Retrieval/Aspiration System | Inari Medical | 2019 | — |
| −5 | K191710 | FlowTriever Retrieval/Aspiration System | Inari Medical | 2019 | — |
| −4 | K202345 | FlowTriever Retrieval/Aspiration System | Inari Medical | 2020 | — |
| −3 | K211013 | FlowTriever Retrieval/Aspiration System, FlowTriever Catheters, Triever 16… | Inari Medical, Inc. | 2021 | — |
| −2 | K213402 | Triever24, Triever20 | Inari Medical | 2022 | — |
| −1 | K223897 | Excipio LV Thrombectomy Device | Contego Medical, Inc. | 2023 | — |
| 0 (this device) | K251485 | Excipio LV Prime Thrombectomy Device | Contego Medical, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 2 | 1 |
| 1998 | 4 | 1 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 1 |
| 2004 | 1 | 0 |
| 2009 | 1 | 0 |
| 2013 | 1 | 0 |
| 2022 | 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.
3 devices in this family have a Class I recall. 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 QEW device
- #1 K213402 Triever24, Triever20score 28.6 · 5 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 |
|---|---|---|---|
| * | K223897 | Excipio LV Thrombectomy DeviceSummary page 5…1 CFR §870.5150 Classification Name: Catheter, Embolectomy Product Code: QEW Predicate Device: Excipio LV Thrombectomy Device (K223897) Reference Devices: Excipio SV Thrombectomy Device (K221204) Intended Use/Indications for Use: The Excipio LV Prime… | 2023 |
| † | K221204 | Excipio SV Thrombectomy Device | 2022 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (3 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K022145Over the Wire Embolectomy Catheter, Model 2302LeMaitre Vascular, Inc. · 2003 · 6 generations back · ◆ in the 2003 ancestors bar of FIG. 11 Class I recall
- K973465Latis Graft Cleaning CatheterApplied Medical Resources · 1998 · 6 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K970762Dual Lumen Embolectomy CatheterApplied Medical Resources · 1997 · 7 generations back · ◆ in the 1997 ancestors bar of FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 7 years and passes through 3 companies; a new generation was cleared every 9 months on median.
- 4 of the 25 ancestors have a recall of any class; 3 have a Class I recall.
How does its category compare?
All QEW devicesQEW Peripheral Mechanical Thrombectomy With Aspiration: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · QEW
14in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QEW
58in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QEW
7in 2022
Class I (7 since 2007) Class II/III not classified
Adverse event reports per year · QEW
207in 2025
MAUDE reports naming product code QEW, 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 | 2 | — | 0 | 0 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 2 | — | 0 | 0 |
| 2015 | 4 | 88 | 0 | 0 |
| 2016 | 4 | 63 | 0 | 0 |
| 2017 | 2 | — | 0 | 0 |
| 2018 | 14 | 61 | 0 | 0 |
| 2019 | 8 | 51 | 0 | 33 |
| 2020 | 16 | 105 | 0 | 197 |
| 2021 | 11 | 60 | 0 | 322 |
| 2022 | 12 | 140 | 7 (7) | 125 |
| 2023 | 23 | 102 | 0 | 165 |
| 2024 | 14 | 65 | 0 | 162 |
| 2025 | 14 | 58 | 0 | 207 |
| 2026 | 10 | 74 | 0 | — |
What is it indicated for?
The Excipio LV Prime Thrombectomy Device is indicated for the nonsurgical removal of emboli and thrombi from peripheral blood vessels.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251485 · printed Nov 5, 2026
Cite this page
510(k) Report. “K251485: Excipio LV Prime Thrombectomy Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K251485
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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