510(k) · Cleared
Recalled · Class II · 2025Artix™ MT; Artix™ Thin-Walled Thrombectomy Sheath
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 Oct 15, 2024 as substantially equivalent to K220600 (Inari Medical, 2022) and 1 other predicate after a 109-day review. Its family tree reaches back 19 generations to 1990. 3 of the 49 devices in its family, counting itself, have a Class I recall. 1 later device descends from it. It has been recalled once.
- Decided
- Oct 15, 2024
- Review
- 109 days
- Class
- Class II
- Product code
- QEW
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 19 generations to K901627 (1990). 47 ancestors in all, the oldest K780551 (1978). 1 later device descends from it, 1 citing it directly. 3 of the 49 devices in this family, counting this one, have a Class I recall.
- Root · 19 generations backK901627 Arterial Embolectomy CatheterApplied Vascular Devices, Inc. · 1990 · Recalled
- 15 generations between
- 3 generations backK212632 ClotTriever Thrombectomy SystemInari Medical, Inc. · 2021
- 2 generations backK223000 Artix BGInari Medical · 2023
- 1 generation backK230912 Artix BGInari Medical · 2023
- This deviceK241894 Artix™ MT; Artix™ Thin-Walled Thrombectomy SheathInari Medical, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK262538 Artix™ MT;Artix™ Thin-Walled SheathInari Medical, Inc. · 2026
Show all 19 generations
- Root · 19 generations backK901627 Arterial Embolectomy CatheterApplied Vascular Devices, Inc. · 1990 · Recalled
- 18 generations backK960970 Possis Angiojet Rapid Thrombectomy Catheter System, F105…Possis Medical, Inc. · 1996
- 17 generations backK972610 Possis Angiojet Rapid Thombectomy Catheters--F105 Catheter Model…Possis Medical, Inc. · 2000
- 16 generations backK040013 Angiojet Xpeedior 120 Catheter and Angiojet Power Pulse Spray…Possis Medical, Inc. · 2004
- 15 generations backK052256 Angiojet Xpeedior 120 CatheterPossis Medical, Inc. · 2005
- 14 generations backK061951 Angiojet Xpeedior Rheolytic Thrombectomy Catheter, Model Xpeedior 120Possis Medical, Inc. · 2006
- 13 generations backK071342 Angiojet Ultra Xpeedior Thrombectomy Set, Model 105040, 105042…Possis Medical, Inc. · 2007
- 12 generations backK072269 Angiojet Ultra DVX Thrombectomy Set, Model: 106552Possis Medical, Inc. · 2007
- 11 generations backK090253 Angiojet Ultra DVX Thrombectomy Set, Model 106552-001, Angiojet…Possis Medical, Inc. · 2009
- 10 generations backK091593 Angio Jet Ultra DVX and Xpeedior Thrombectomy SetsPossis Medical, Inc. · 2009
- 9 generations backK101406 Angiojet Solent Proxi Thrombectomy Set Model 109676-001Medrad Interventional/Possis · 2010
- 8 generations backK111182 Angiojet Solent Omni Thrombectomy SetMedrad, Inc. · 2011 · Recalled
- 7 generations backK151313 ZelanteDVT Thrombectomy SetBoston Scientific Corporation · 2015
- 6 generations backK193462 ClotTriever Thrombectomy SystemInari Medical · 2020
- 5 generations backK210190 ClotTriever Thrombectomy SystemIrani Medical, Inc. · 2021
- 4 generations backK210689 ClotTriever Thrombectomy SystemInari Medical, Inc. · 2021
- 3 generations backK212632 ClotTriever Thrombectomy SystemInari Medical, Inc. · 2021
- 2 generations backK223000 Artix BGInari Medical · 2023
- 1 generation backK230912 Artix BGInari Medical · 2023
- This deviceK241894 Artix™ MT; Artix™ Thin-Walled Thrombectomy SheathInari Medical, Inc. · 2024
Class I recalls in this family
Most influential descendants
Showing 1 of 1 · See all- K262538Artix™ MT;Artix™ Thin-Walled SheathInari Medical, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −19 | K901627 | Arterial Embolectomy Catheter | Applied Vascular Devices, Inc. | 1990 | 1 |
| −18 | K960970 | Possis Angiojet Rapid Thrombectomy Catheter System, F105 Catheter,Model… | Possis Medical, Inc. | 1996 | — |
| −17 | K972610 | Possis Angiojet Rapid Thombectomy Catheters--F105 Catheter Model 3030C, LF140… | Possis Medical, Inc. | 2000 | — |
| −16 | K040013 | Angiojet Xpeedior 120 Catheter and Angiojet Power Pulse Spray Ancillary Kit | Possis Medical, Inc. | 2004 | — |
| −15 | K052256 | Angiojet Xpeedior 120 Catheter | Possis Medical, Inc. | 2005 | — |
| −14 | K061951 | Angiojet Xpeedior Rheolytic Thrombectomy Catheter, Model Xpeedior 120 | Possis Medical, Inc. | 2006 | — |
| −13 | K071342 | Angiojet Ultra Xpeedior Thrombectomy Set, Model 105040, 105042, 106552… | Possis Medical, Inc. | 2007 | — |
| −12 | K072269 | Angiojet Ultra DVX Thrombectomy Set, Model: 106552 | Possis Medical, Inc. | 2007 | — |
| −11 | K090253 | Angiojet Ultra DVX Thrombectomy Set, Model 106552-001, Angiojet Ultra Xpeedior… | Possis Medical, Inc. | 2009 | — |
| −10 | K091593 | Angio Jet Ultra DVX and Xpeedior Thrombectomy Sets | Possis Medical, Inc. | 2009 | — |
| −9 | K101406 | Angiojet Solent Proxi Thrombectomy Set Model 109676-001 | Medrad Interventional/Possis | 2010 | — |
| −8 | K111182 | Angiojet Solent Omni Thrombectomy Set | Medrad, Inc. | 2011 | 1 |
| −7 | K151313 | ZelanteDVT Thrombectomy Set | Boston Scientific Corporation | 2015 | — |
| −6 | K193462 | ClotTriever Thrombectomy System | Inari Medical | 2020 | — |
| −5 | K210190 | ClotTriever Thrombectomy System | Irani Medical, Inc. | 2021 | — |
| −4 | K210689 | ClotTriever Thrombectomy System | Inari Medical, Inc. | 2021 | — |
| −3 | K212632 | ClotTriever Thrombectomy System | Inari Medical, Inc. | 2021 | — |
| −2 | K223000 | Artix BG | Inari Medical | 2023 | — |
| −1 | K230912 | Artix BG | Inari Medical | 2023 | — |
| 0 (this device) | K241894 | Artix™ MT; Artix™ Thin-Walled Thrombectomy Sheath | Inari Medical, Inc. | 2024 | — |
| +1 | K262538 | Artix™ MT;Artix™ Thin-Walled Sheath | Inari Medical, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1983 | 1 | 0 |
| 1989 | 1 | 0 |
| 1991 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1997 | 2 | 1 |
| 1998 | 4 | 1 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 1 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2015 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K220600 | Artix Thrombectomy DeviceSummary page 5…ode(s) QEW; KRA Regulation(s) 21 CFR 870.5150 Embolectomy catheter Regulatory class II Predicate device Inari Medical, Artix Thrombectomy Device (K220600) This device has not been subject to a design-related recall. Reference devices Surmodics, Pounce LP Th… | 2022 |
| * | K230912 | Artix BGSummary page 9…Sheath Product code(s) QEW; DQY Regulation 21 CFR 870.5150 Embolectomy catheter Regulatory class II Predicate device Inari Medical, Artix BG (K230912) This device has not been subject to a design-related recall. Reference device(s) Surmodics, Pounce Throm… | 2023 |
| † | K231022 | Pounce™ Thrombectomy System | 2023 |
| † | K203476 | CAPERE Thrombectomy System | 2020 |
| † | K201541 | FlowTriever Retrieval/Aspiration System | 2020 |
| † | K223613 | InThrill Thrombectomy System | 2023 |
| † | K171493 | MegaVac Mechanical Thrombectomy System | 2017 |
| † | K233815 | ClotTriever Sheath | 2023 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K262538 | Artix™ MT;Artix™ Thin-Walled Sheath | 2026 | 0 |
Has anything in its family been recalled? (3 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 8, 2025 | Class II | Z-1728-2025 | Labeling Change Control | Thrombectomy device specifies vessel range of 2.5-6 mm on the pouch, carton, and Instructions for Use rather than the correct vessel range of 3-6 mm, which could incrementally increase the radial force on the artery, which has the… |
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 · 5 generations back · ◆ in the 2003 ancestors bar of FIG. 11 Class I recall
- K973465Latis Graft Cleaning CatheterApplied Medical Resources · 1998 · 5 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K970762Dual Lumen Embolectomy CatheterApplied Medical Resources · 1997 · 6 generations back · ◆ in the 1997 ancestors bar of FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 34 years and passes through 8 companies; a new generation was cleared every 1.0 years on median.
- 11 of the 47 ancestors have a recall of any class; 3 have a Class I recall.
- Of its descendants, K262538 (Inari Medical, Inc., 2026) has gone furthest, with 0 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. 2024, 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 ArtixTM MT thrombectomy device 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 ArtixTM MT thrombectomy device is intended for use in the peripheral vasculature. The ArtixTM Thin-Walled Sheath is indicated for: *The non-surgical removal of emboli and thrombi from blood vessels. *Injection, infusion, and/or…
Read the full statement (127 words)
The ArtixTM MT thrombectomy device 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 ArtixTM MT thrombectomy device is intended for use in the peripheral vasculature.
The ArtixTM Thin-Walled Sheath 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.
*Use as a conduit for endovascular devices.
Use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel. The funnel provides temporary vascular occlusion during these and other angiographic procedures.
The ArtixTM Thin-Walled Sheath is intended for use in the peripheral vasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K241894 · printed Nov 6, 2026
Cite this page
510(k) Report. “K241894: Artix™ MT; Artix™ Thin-Walled Thrombectomy Sheath.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K241894
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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