510(k) · Cleared
ClearedFlowTriever Retrieval/Aspiration System, FlowTriever Catheters, Triever 16, Triever 20, Triever 20 Curve, Triever 24
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Inari Medical, Inc. · QEW Peripheral Mechanical Thrombectomy With Aspiration
Cleared on Apr 30, 2021 as substantially equivalent to K202345 (Inari Medical, 2020) after a 25-day review. Its family tree reaches back 4 generations to 2018. 12 later devices descend from it.
- Decided
- Apr 30, 2021
- Review
- 25 days
- Class
- Class II
- Product code
- QEW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K183198 (2018). 12 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK183198 FlowTriever Retrieval/Aspiration SystemInari Medical · 2018
- 3 generations backK191368 FlowTriever Retrieval/Aspiration SystemInari Medical · 2019
- 2 generations backK191710 FlowTriever Retrieval/Aspiration SystemInari Medical · 2019
- 1 generation backK202345 FlowTriever Retrieval/Aspiration SystemInari Medical · 2020
- This deviceK211013 FlowTriever Retrieval/Aspiration System, FlowTriever Catheters…Inari Medical, Inc. · 2021
- Descendant · cites it directly · 9 of its ownK213402 Triever24, Triever20Inari Medical · 2022
- Descendant · cites it directly · 1 of its ownK223929 Laguna™ Clot Retriever System and Malibu™ Aspiration Catheter System…Innova Vascular, Inc. · 2023
- Descendant · 2 generations on · 1 of its ownK223897 Excipio LV Thrombectomy DeviceContego Medical, Inc. · 2023
- Descendant · 2 generations on · 0 of its ownK253419 Triever Duo CatheterInari Medical, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK254035 Mayumi™ Thrombectomy SystemMicroVention, Inc., d/b/a Terumo Neuro · 2026
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K213402Triever24, Triever20Inari Medical · 2022 · cites it directly9descendants
- K223929Laguna™ Clot Retriever System and Malibu™ Aspiration Catheter System (Laguna…Innova Vascular, Inc. · 2023 · cites it directly1descendant
- K223897Excipio LV Thrombectomy DeviceContego Medical, Inc. · 2023 · 2 generations on1descendant
- K253419Triever Duo CatheterInari Medical, Inc. · 2026 · 2 generations on0descendants
- K254035Mayumi™ Thrombectomy SystemMicroVention, Inc., d/b/a Terumo Neuro · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K183198 | FlowTriever Retrieval/Aspiration System | Inari Medical | 2018 | — |
| −3 | K191368 | FlowTriever Retrieval/Aspiration System | Inari Medical | 2019 | — |
| −2 | K191710 | FlowTriever Retrieval/Aspiration System | Inari Medical | 2019 | — |
| −1 | K202345 | FlowTriever Retrieval/Aspiration System | Inari Medical | 2020 | — |
| 0 (this device) | K211013 | FlowTriever Retrieval/Aspiration System, FlowTriever Catheters, Triever 16… | Inari Medical, Inc. | 2021 | — |
| +1 | K213402 | Triever24, Triever20 | Inari Medical | 2022 | — |
| +1 | K223929 | Laguna™ Clot Retriever System and Malibu™ Aspiration Catheter System (Laguna… | Innova Vascular, Inc. | 2023 | — |
| +2 | K223897 | Excipio LV Thrombectomy Device | Contego Medical, Inc. | 2023 | — |
| +2 | K253419 | Triever Duo Catheter | Inari Medical, Inc. | 2026 | — |
| +2 | K254035 | Mayumi™ Thrombectomy System | MicroVention, Inc., d/b/a Terumo Neuro | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 6 | 0 |
| 2025 | 3 | 0 |
| 2026 | 2 | 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 QEW? 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 |
|---|---|---|---|
| * | K202345 | FlowTriever Retrieval/Aspiration SystemSummary page 4…0.5150 Product code QEW Secondary Product KRA Code Regulatory class II Predicate device Inari FlowTriever Retrieval/Aspiration System (K202345) Reference Device Inari FlowTriever Retrieval/Aspiration System (K201541) Description The FlowTriever Retrie… | 2020 |
| † | K201541 | FlowTriever Retrieval/Aspiration System | 2020 |
What descends from it? (12)
See all 122 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 3 years and passes through 2 companies; a new generation was cleared every 6 months on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K213402 (Inari Medical, 2022) has gone furthest, with 9 descendants of its own.
- 1 other device also cites its predicate K202345.
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. 2021, 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 FlowTriever Retrieval/Aspiration System is indicated for:
* The non-surgical removal of emboli and thrombi from blood vessels.
* Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel.
The FlowTriever Retrieval/Aspiration System is intended for use in the peripheral vasculature and for the treatment of pulmonary embolism.
Triever Catheters (Triever 16, Triever 20, Triever 20 Curve, and Triever 24) are also intended for use in treating clot in transit in the right atrium but not in conjunction with FlowTriever Catheters.
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/K211013 · printed Nov 3, 2026
Cite this page
510(k) Report. “K211013: FlowTriever Retrieval/Aspiration System, FlowTriever Catheters, Triever 16, Triever 20, Triever 20 Curve, Triever 24.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K211013
Report an extraction error
Are you the manufacturer?
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