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, Inc. · QEW Peripheral Mechanical Thrombectomy With Aspiration
Cleared on Jun 17, 2018 as substantially equivalent to K180466 (Inari Medical, Inc., 2018) and 1 other predicate after a 30-day review. Its family tree reaches back 6 generations to 1983. 3 of the 23 devices in its family, counting itself, have a Class I recall. 2 later devices descend from it.
- Decided
- Jun 17, 2018
- Review
- 30 days
- Class
- Class II
- Product code
- QEW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K832023 (1983). 20 ancestors in all. 2 later devices descend from it, 1 citing it directly. 3 of the 23 devices in this family, counting this one, have a Class I recall.
- Root · 6 generations backK832023 Embolectomy CatheterBionomy, Inc. · 1983
- 5 generations backK961883 Versa-Cath Arterial CatheterIdeas For Medicine, Inc. · 1997
- 4 generations backK040010 Genesis Medical Interventional F.a.S.T. (Facilitated…Genesis Medical Interventional, Inc. · 2004
- 3 generations backK143563 Infusion Aspiration Catheter SystemInari Medical, Inc. · 2015
- 2 generations backK162970 FlowTriever Retrieval/Aspiration System, Aspiration Guide Catheter…Inari Medical · 2016
- 1 generation backK173672 FlowTriever Retrieval/Aspiration System, Aspiration Guide CatheterInari Medical · 2018
- This deviceK181325 FlowTriever Retrieval/Aspiration SystemInari Medical, Inc. · 2018
- Descendant · cites it directly · 1 of its ownK181694 FlowTriever Retrieval/Aspiration SystemInari Medical · 2018
- Descendant · 2 generations on · 0 of its ownK182233 FlowTriever Retrieval/Aspiration SystemInari Medical · 2018 · Recalled
Class I recalls in this family
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K832023 | Embolectomy Catheter | Bionomy, Inc. | 1983 | — |
| −5 | K961883 | Versa-Cath Arterial Catheter | Ideas For Medicine, Inc. | 1997 | — |
| −4 | K040010 | Genesis Medical Interventional F.a.S.T. (Facilitated Aspiration/Suction… | Genesis Medical Interventional, Inc. | 2004 | — |
| −3 | K143563 | Infusion Aspiration Catheter System | Inari Medical, Inc. | 2015 | — |
| −2 | K162970 | FlowTriever Retrieval/Aspiration System, Aspiration Guide Catheter, Retraction… | Inari Medical | 2016 | — |
| −1 | K173672 | FlowTriever Retrieval/Aspiration System, Aspiration Guide Catheter | Inari Medical | 2018 | — |
| 0 (this device) | K181325 | FlowTriever Retrieval/Aspiration System | Inari Medical, Inc. | 2018 | — |
| +1 | K181694 | FlowTriever Retrieval/Aspiration System | Inari Medical | 2018 | — |
| +2 | K182233 | FlowTriever Retrieval/Aspiration System | Inari Medical | 2018 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 1 |
| 1998 | 4 | 1 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 1 |
| 2018 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 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.
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? (2)
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 |
|---|---|---|---|
| * | K180466 | FlowTriever Retrieval/Aspiration SystemSummary page 4…Classification number 21 CFR 870.5150 Product code DXE Regulatory class II Predicate devices Inari FlowTriever Retrieval/Aspiration System (K180466) (Primary Predicate) Inari FlowTriever Retrieval/Aspiration System (K173672) Description The… | 2018 |
| * | K173672 | FlowTriever Retrieval/Aspiration System, Aspiration Guide CatheterSummary page 4…redicate devices Inari FlowTriever Retrieval/Aspiration System (K180466) (Primary Predicate) Inari FlowTriever Retrieval/Aspiration System (K173672) Description The FlowTriever Retrieval/Aspiration System is a single-use over-the-wire cathe… | 2018 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K181694 | FlowTriever Retrieval/Aspiration System | 2018 | 1 |
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 · 4 generations back · ◆ in the 2003 ancestors bar of FIG. 11 Class I recall
- K973465Latis Graft Cleaning CatheterApplied Medical Resources · 1998 · 4 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K970762Dual Lumen Embolectomy CatheterApplied Medical Resources · 1997 · 5 generations back · ◆ in the 1997 ancestors bar of FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 35 years and passes through 5 companies; a new generation was cleared every 7.5 years on median.
- 5 of the 20 ancestors have a recall of any class; 3 have a Class I recall.
- Of its descendants, K181694 (Inari Medical, 2018) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K180466.
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. 2018, 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 consists of the FlowTriever Catheter, Aspiration Guide Catheter, and Retraction Aspirator. 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/K181325 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181325: 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/K181325
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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