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 Jun 17, 2019 as substantially equivalent to K183198 (Inari Medical, 2018) after a 26-day review. Its family tree reaches back 1 generation to 2018. 21 later devices descend from it.
- Decided
- Jun 17, 2019
- Review
- 26 days
- Class
- Class II
- Product code
- QEW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K183198 (2018). 21 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK183198 FlowTriever Retrieval/Aspiration SystemInari Medical · 2018
- This deviceK191368 FlowTriever Retrieval/Aspiration SystemInari Medical · 2019
- Descendant · cites it directly · 20 of its ownK191710 FlowTriever Retrieval/Aspiration SystemInari Medical · 2019
- Descendant · 2 generations on · 14 of its ownK202345 FlowTriever Retrieval/Aspiration SystemInari Medical · 2020
- Descendant · 3 generations on · 12 of its ownK211013 FlowTriever Retrieval/Aspiration System, FlowTriever Catheters…Inari Medical, Inc. · 2021
- Descendant · 4 generations on · 9 of its ownK213402 Triever24, Triever20Inari Medical · 2022
- Descendant · 2 generations on · 3 of its ownK251189 Aventus Thrombectomy SystemInquis Medical · 2025
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 21 · See all- K191710FlowTriever Retrieval/Aspiration SystemInari Medical · 2019 · cites it directly20descendants
- K202345FlowTriever Retrieval/Aspiration SystemInari Medical · 2020 · 2 generations on14descendants
- K211013FlowTriever Retrieval/Aspiration System, FlowTriever Catheters, Triever 16, Triever 20…Inari Medical, Inc. · 2021 · 3 generations on12descendants
- K213402Triever24, Triever20Inari Medical · 2022 · 4 generations on9descendants
- K251189Aventus Thrombectomy SystemInquis Medical · 2025 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K183198 | FlowTriever Retrieval/Aspiration System | Inari Medical | 2018 | — |
| 0 (this device) | K191368 | FlowTriever Retrieval/Aspiration System | Inari Medical | 2019 | — |
| +1 | K191710 | FlowTriever Retrieval/Aspiration System | Inari Medical | 2019 | — |
| +2 | K202345 | FlowTriever Retrieval/Aspiration System | Inari Medical | 2020 | — |
| +3 | K211013 | FlowTriever Retrieval/Aspiration System, FlowTriever Catheters, Triever 16… | Inari Medical, Inc. | 2021 | — |
| +4 | K213402 | Triever24, Triever20 | Inari Medical | 2022 | — |
| +2 | K251189 | Aventus Thrombectomy System | Inquis Medical | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 6 | 0 |
| 2025 | 4 | 0 |
| 2026 | 5 | 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 |
|---|---|---|---|
| * | K183198 | FlowTriever Retrieval/Aspiration SystemSummary page 4…Classification number 21 CFR 870.5150 Product code QEW Regulatory class II Predicate device Inari FlowTriever Retrieval/Aspiration System (K183198) Reference device Inari FlowTriever Retrieval/Aspiration System (K182233) Description The FlowTriever Retrie… | 2018 |
| † | K182233 | FlowTriever Retrieval/Aspiration System | 2018 |
What descends from it? (21)
See all 211 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K191710 | FlowTriever Retrieval/Aspiration System | 2019 | 20 |
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?
- Its one ancestor has no recall.
- Of its descendants, K191710 (Inari Medical, 2019) has gone furthest, with 20 descendants of its own.
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. 2019, 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K191368 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191368: FlowTriever Retrieval/Aspiration System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191368
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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