510(k) · Cleared
ClearedInfusion Aspiration Catheter 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 Feb 3, 2015 as substantially equivalent to K040010 (Genesis Medical Interventional, Inc., 2004) and 1 other predicate after a 49-day review. Its family tree reaches back 3 generations to 1983. 3 of the 52 devices in its family, counting itself, have a Class I recall. 35 later devices descend from it.
- Decided
- Feb 3, 2015
- Review
- 49 days
- Class
- Class II
- Product code
- QEW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K832023 (1983). 16 ancestors in all. 35 later devices descend from it, 7 citing it directly. 3 of the 52 devices in this family, counting this one, have a Class I recall.
- Root · 3 generations backK832023 Embolectomy CatheterBionomy, Inc. · 1983
- 2 generations backK961883 Versa-Cath Arterial CatheterIdeas For Medicine, Inc. · 1997
- 1 generation backK040010 Genesis Medical Interventional F.a.S.T. (Facilitated…Genesis Medical Interventional, Inc. · 2004
- This deviceK143563 Infusion Aspiration Catheter SystemInari Medical, Inc. · 2015
- Descendant · cites it directly · 6 of its ownK163549 ClotTriever Thrombectomy SystemInari Medical, Inc. · 2017
- Descendant · cites it directly · 6 of its ownK162970 FlowTriever Retrieval/Aspiration System, Aspiration Guide Catheter…Inari Medical · 2016
- Descendant · cites it directly · 5 of its ownK182835 WOLF Thrombectomy Device880 Medical, LLC · 2019
- Descendant · cites it directly · 5 of its ownK180722 CAPERE Thrombectomy SystemKp Medcure, Inc. · 2018
- Descendant · cites it directly · 5 of its ownK180466 FlowTriever Retrieval/Aspiration SystemInari Medical, Inc. · 2018
Showing 5 of 35 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 35 · See all- K163549ClotTriever Thrombectomy SystemInari Medical, Inc. · 2017 · cites it directly6descendants
- K162970FlowTriever Retrieval/Aspiration System, Aspiration Guide Catheter, Retraction AspiratorInari Medical · 2016 · cites it directly6descendants
- K182835WOLF Thrombectomy Device880 Medical, LLC · 2019 · cites it directly5descendants
- K180722CAPERE Thrombectomy SystemKp Medcure, Inc. · 2018 · cites it directly5descendants
- K180466FlowTriever Retrieval/Aspiration SystemInari Medical, Inc. · 2018 · cites it directly5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K832023 | Embolectomy Catheter | Bionomy, Inc. | 1983 | — |
| −2 | K961883 | Versa-Cath Arterial Catheter | Ideas For Medicine, Inc. | 1997 | — |
| −1 | K040010 | Genesis Medical Interventional F.a.S.T. (Facilitated Aspiration/Suction… | Genesis Medical Interventional, Inc. | 2004 | — |
| 0 (this device) | K143563 | Infusion Aspiration Catheter System | Inari Medical, Inc. | 2015 | — |
| +1 | K163549 | ClotTriever Thrombectomy System | Inari Medical, Inc. | 2017 | — |
| +1 | K162970 | FlowTriever Retrieval/Aspiration System, Aspiration Guide Catheter, Retraction… | Inari Medical | 2016 | — |
| +1 | K182835 | WOLF Thrombectomy Device | 880 Medical, LLC | 2019 | — |
| +1 | K180722 | CAPERE Thrombectomy System | Kp Medcure, Inc. | 2018 | — |
| +1 | K180466 | FlowTriever Retrieval/Aspiration System | Inari Medical, Inc. | 2018 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 8 | 0 |
| 2019 | 5 | 0 |
| 2020 | 6 | 0 |
| 2021 | 3 | 0 |
| 2022 | 3 | 0 |
| 2023 | 1 | 0 |
| 2024 | 3 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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? (3)
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 |
|---|---|---|---|
| * | K040010 | Genesis Medical Interventional F.a.S.T. (Facilitated Aspiration/Suction Thrombectomy)…Summary page 4…ification number 21 CFR 870.5150 Product code DXE Regulatory class II Predicate devices Genesis Medical Interventional F.A .S.T. System (K040010) Fogarty Thru-Lumen Embolectomy Catheter (K892410) Fogarty Venous Embolectomy C… | 2004 |
| * | K892410 | Fogarty (R) Thru-Lumen Embolectomy CatheterSummary page 4…ry class II Predicate devices Genesis Medical Interventional F.A .S.T. System (K040010) Fogarty Thru-Lumen Embolectomy Catheter (K892410) Fogarty Venous Embolectomy Catheter (510[k] unknown) Description The Infusion Wireform Ca… | 1989 |
| * | — | Fogarty Venous Embolectomy Catheter Named without a submission number |
What descends from it? (35)
See all 357 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K163549 | ClotTriever Thrombectomy System | 2017 | 6 |
| K162970 | FlowTriever Retrieval/Aspiration System, Aspiration Guide Catheter, Retraction Aspirator | 2016 | 6 |
| K182835 | WOLF Thrombectomy Device | 2019 | 5 |
| K180722 | CAPERE Thrombectomy System | 2018 | 5 |
| K180466 | FlowTriever Retrieval/Aspiration System | 2018 | 5 |
| K201541 | FlowTriever Retrieval/Aspiration System | 2020 | 4 |
| K152097 | Retraction Aspirator | 2015 | 0 |
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 · 2 generations back · ◆ in the 2003 ancestors bar of FIG. 11 Class I recall
- K973465Latis Graft Cleaning CatheterApplied Medical Resources · 1998 · 2 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K970762Dual Lumen Embolectomy CatheterApplied Medical Resources · 1997 · 3 generations back · ◆ in the 1997 ancestors bar of FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 32 years and passes through 4 companies; a new generation was cleared every 10.5 years on median.
- 5 of the 16 ancestors have a recall of any class; 3 have a Class I recall.
- Of its descendants, K163549 (Inari Medical, Inc., 2017) has gone furthest, with 6 descendants of its own.
- 2 other devices also cite its predicate K040010.
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. 2015, 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 Infusion Aspiration Catheter System consists of the Infusion Wire Catheter, Aspiration Guide Catheter, and Retraction Aspirator Device. The Infusion Aspiration Catheter 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 Infusion Aspiration Catheter System is intended for use in the peripheral vasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K143563 · printed Nov 4, 2026
Cite this page
510(k) Report. “K143563: Infusion Aspiration Catheter System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K143563
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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