510(k) · Cleared
ClearedFlowTriever Retrieval/Aspiration System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Inari Medical · QEW Peripheral Mechanical Thrombectomy With Aspiration
Cleared on Dec 18, 2020 as substantially equivalent to K191710 (Inari Medical, 2019) after a 122-day review. Its family tree reaches back 3 generations to 2018. 14 later devices descend from it.
- Decided
- Dec 18, 2020
- Review
- 122 days
- Class
- Class II
- Product code
- QEW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K183198 (2018). 14 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK183198 FlowTriever Retrieval/Aspiration SystemInari Medical · 2018
- 2 generations backK191368 FlowTriever Retrieval/Aspiration SystemInari Medical · 2019
- 1 generation backK191710 FlowTriever Retrieval/Aspiration SystemInari Medical · 2019
- This deviceK202345 FlowTriever Retrieval/Aspiration SystemInari Medical · 2020
- Descendant · cites it directly · 12 of its ownK211013 FlowTriever Retrieval/Aspiration System, FlowTriever Catheters…Inari Medical, Inc. · 2021
- Descendant · 2 generations on · 9 of its ownK213402 Triever24, Triever20Inari Medical · 2022
- Descendant · 2 generations on · 1 of its ownK223929 Laguna™ Clot Retriever System and Malibu™ Aspiration Catheter System…Innova Vascular, Inc. · 2023
- Descendant · 3 generations on · 1 of its ownK223897 Excipio LV Thrombectomy DeviceContego Medical, Inc. · 2023
- Descendant · 3 generations on · 0 of its ownK253419 Triever Duo CatheterInari Medical, Inc. · 2026
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K211013FlowTriever Retrieval/Aspiration System, FlowTriever Catheters, Triever 16, Triever 20…Inari Medical, Inc. · 2021 · cites it directly12descendants
- K213402Triever24, Triever20Inari Medical · 2022 · 2 generations on9descendants
- K223929Laguna™ Clot Retriever System and Malibu™ Aspiration Catheter System (Laguna…Innova Vascular, Inc. · 2023 · 2 generations on1descendant
- K223897Excipio LV Thrombectomy DeviceContego Medical, Inc. · 2023 · 3 generations on1descendant
- K253419Triever Duo CatheterInari Medical, Inc. · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K183198 | FlowTriever Retrieval/Aspiration System | Inari Medical | 2018 | — |
| −2 | K191368 | FlowTriever Retrieval/Aspiration System | Inari Medical | 2019 | — |
| −1 | K191710 | FlowTriever Retrieval/Aspiration System | Inari Medical | 2019 | — |
| 0 (this device) | K202345 | FlowTriever Retrieval/Aspiration System | Inari Medical | 2020 | — |
| +1 | K211013 | FlowTriever Retrieval/Aspiration System, FlowTriever Catheters, Triever 16… | Inari Medical, Inc. | 2021 | — |
| +2 | K213402 | Triever24, Triever20 | Inari Medical | 2022 | — |
| +2 | K223929 | Laguna™ Clot Retriever System and Malibu™ Aspiration Catheter System (Laguna… | Innova Vascular, Inc. | 2023 | — |
| +3 | K223897 | Excipio LV Thrombectomy Device | Contego Medical, Inc. | 2023 | — |
| +3 | K253419 | Triever Duo Catheter | Inari Medical, Inc. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 2 | 0 |
| 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 |
|---|---|---|---|
| * | K191710 | FlowTriever Retrieval/Aspiration SystemSummary page 4…catheter Classification number 21 CFR 870.5150 Product code QEW Regulatory class II Predicate device FlowTriever Retrieval/Aspiration System (K191710) Reference device AngioVac Cannula (K190594) Description The FlowTriever Retrieval/Aspiration System is a sing… | 2019 |
| † | K190594 | AngioVac C20, AngioVac C180 | 2019 |
What descends from it? (14)
See all 142 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 2 years and passes through 1 company; a new generation was cleared every 6 months on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K211013 (Inari Medical, Inc., 2021) has gone furthest, with 12 descendants of its own.
- 2 other devices also cite its predicate K191710.
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. 2020, 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?
Triever Catheters are 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.
Triever Catheters are intended for use in the peripheral vasculature and for the treatment of pulmonary embolism. Triever Catheters are also intended for use in treating clot in transit in the right atrium, but not in conjunction with FlowTriever Catheters.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K202345 · printed Nov 5, 2026
Cite this page
510(k) Report. “K202345: FlowTriever Retrieval/Aspiration System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K202345
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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