510(k) · Cleared
ClearedArtix BG
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 Jan 11, 2023 as substantially equivalent to K212632 (Inari Medical, Inc., 2021) after a 105-day review. Its family tree reaches back 17 generations to 1990. 3 later devices descend from it.
- Decided
- Jan 11, 2023
- Review
- 105 days
- Class
- Class II
- Product code
- QEW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 17 generations to K901627 (1990). 26 ancestors in all, the oldest K780551 (1978). 3 later devices descend from it, 1 citing it directly.
- Root · 17 generations backK901627 Arterial Embolectomy CatheterApplied Vascular Devices, Inc. · 1990 · Recalled
- 13 generations between
- 3 generations backK210190 ClotTriever Thrombectomy SystemIrani Medical, Inc. · 2021
- 2 generations backK210689 ClotTriever Thrombectomy SystemInari Medical, Inc. · 2021
- 1 generation backK212632 ClotTriever Thrombectomy SystemInari Medical, Inc. · 2021
- This deviceK223000 Artix BGInari Medical · 2023
- Descendant · cites it directly · 2 of its ownK230912 Artix BGInari Medical · 2023
- Descendant · 2 generations on · 1 of its ownK241894 Artix™ MT; Artix™ Thin-Walled Thrombectomy SheathInari Medical, Inc. · 2024 · Recalled
- Descendant · 3 generations on · 0 of its ownK262538 Artix™ MT;Artix™ Thin-Walled SheathInari Medical, Inc. · 2026
Show all 17 generations
- Root · 17 generations backK901627 Arterial Embolectomy CatheterApplied Vascular Devices, Inc. · 1990 · Recalled
- 16 generations backK960970 Possis Angiojet Rapid Thrombectomy Catheter System, F105…Possis Medical, Inc. · 1996
- 15 generations backK972610 Possis Angiojet Rapid Thombectomy Catheters--F105 Catheter Model…Possis Medical, Inc. · 2000
- 14 generations backK040013 Angiojet Xpeedior 120 Catheter and Angiojet Power Pulse Spray…Possis Medical, Inc. · 2004
- 13 generations backK052256 Angiojet Xpeedior 120 CatheterPossis Medical, Inc. · 2005
- 12 generations backK061951 Angiojet Xpeedior Rheolytic Thrombectomy Catheter, Model Xpeedior 120Possis Medical, Inc. · 2006
- 11 generations backK071342 Angiojet Ultra Xpeedior Thrombectomy Set, Model 105040, 105042…Possis Medical, Inc. · 2007
- 10 generations backK072269 Angiojet Ultra DVX Thrombectomy Set, Model: 106552Possis Medical, Inc. · 2007
- 9 generations backK090253 Angiojet Ultra DVX Thrombectomy Set, Model 106552-001, Angiojet…Possis Medical, Inc. · 2009
- 8 generations backK091593 Angio Jet Ultra DVX and Xpeedior Thrombectomy SetsPossis Medical, Inc. · 2009
- 7 generations backK101406 Angiojet Solent Proxi Thrombectomy Set Model 109676-001Medrad Interventional/Possis · 2010
- 6 generations backK111182 Angiojet Solent Omni Thrombectomy SetMedrad, Inc. · 2011 · Recalled
- 5 generations backK151313 ZelanteDVT Thrombectomy SetBoston Scientific Corporation · 2015
- 4 generations backK193462 ClotTriever Thrombectomy SystemInari Medical · 2020
- 3 generations backK210190 ClotTriever Thrombectomy SystemIrani Medical, Inc. · 2021
- 2 generations backK210689 ClotTriever Thrombectomy SystemInari Medical, Inc. · 2021
- 1 generation backK212632 ClotTriever Thrombectomy SystemInari Medical, Inc. · 2021
- This deviceK223000 Artix BGInari Medical · 2023
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −17 | K901627 | Arterial Embolectomy Catheter | Applied Vascular Devices, Inc. | 1990 | 1 |
| −16 | K960970 | Possis Angiojet Rapid Thrombectomy Catheter System, F105 Catheter,Model… | Possis Medical, Inc. | 1996 | — |
| −15 | K972610 | Possis Angiojet Rapid Thombectomy Catheters--F105 Catheter Model 3030C, LF140… | Possis Medical, Inc. | 2000 | — |
| −14 | K040013 | Angiojet Xpeedior 120 Catheter and Angiojet Power Pulse Spray Ancillary Kit | Possis Medical, Inc. | 2004 | — |
| −13 | K052256 | Angiojet Xpeedior 120 Catheter | Possis Medical, Inc. | 2005 | — |
| −12 | K061951 | Angiojet Xpeedior Rheolytic Thrombectomy Catheter, Model Xpeedior 120 | Possis Medical, Inc. | 2006 | — |
| −11 | K071342 | Angiojet Ultra Xpeedior Thrombectomy Set, Model 105040, 105042, 106552… | Possis Medical, Inc. | 2007 | — |
| −10 | K072269 | Angiojet Ultra DVX Thrombectomy Set, Model: 106552 | Possis Medical, Inc. | 2007 | — |
| −9 | K090253 | Angiojet Ultra DVX Thrombectomy Set, Model 106552-001, Angiojet Ultra Xpeedior… | Possis Medical, Inc. | 2009 | — |
| −8 | K091593 | Angio Jet Ultra DVX and Xpeedior Thrombectomy Sets | Possis Medical, Inc. | 2009 | — |
| −7 | K101406 | Angiojet Solent Proxi Thrombectomy Set Model 109676-001 | Medrad Interventional/Possis | 2010 | — |
| −6 | K111182 | Angiojet Solent Omni Thrombectomy Set | Medrad, Inc. | 2011 | 1 |
| −5 | K151313 | ZelanteDVT Thrombectomy Set | Boston Scientific Corporation | 2015 | — |
| −4 | K193462 | ClotTriever Thrombectomy System | Inari Medical | 2020 | — |
| −3 | K210190 | ClotTriever Thrombectomy System | Irani Medical, Inc. | 2021 | — |
| −2 | K210689 | ClotTriever Thrombectomy System | Inari Medical, Inc. | 2021 | — |
| −1 | K212632 | ClotTriever Thrombectomy System | Inari Medical, Inc. | 2021 | — |
| 0 (this device) | K223000 | Artix BG | Inari Medical | 2023 | — |
| +1 | K230912 | Artix BG | Inari Medical | 2023 | — |
| +2 | K241894 | Artix™ MT; Artix™ Thin-Walled Thrombectomy Sheath | Inari Medical, Inc. | 2024 | 1 |
| +3 | 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 |
| 1991 | 1 | 0 |
| 1995 | 1 | 0 |
| 2000 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2024 | 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.
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 |
|---|---|---|---|
| * | K212632 | ClotTriever Thrombectomy SystemSummary page 4…0 Product code QEW Secondary product DQY code Regulatory class II Predicate device Inari Medical, ClotTriever Thrombectomy System (K212632) Reference device Inari Medical, Artix Balloon Guiding Sheath (K221846) Description The Artix BG is a sing… | 2021 |
| † | K221846 | Artix Ballon Guiding Sheath | 2022 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K230912 | Artix BG | 2023 | 2 |
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 33 years and passes through 8 companies; a new generation was cleared every 1.0 years on median.
- 6 of the 26 ancestors have a recall of any class.
- Of its descendants, K230912 (Inari Medical, 2023) has gone furthest, with 2 descendants of its own.
- 6 other devices also cite its predicate K212632.
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. 2023, 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 Artix BG balloon thrombectomy sheath is indicated for:
* Use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel. The balloon provides temporary vascular occlusion during these and other angiographic procedures.
* Use as a conduit for retrieval devices.
* The non-surgical aspiration 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 Artix BG balloon thrombectomy sheath is intended for use in the peripheral vasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223000 · printed Nov 4, 2026
Cite this page
510(k) Report. “K223000: Artix BG.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K223000
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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