510(k) · Cleared
ClearedClotTriever Thrombectomy 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 May 12, 2021 as substantially equivalent to K210190 (Irani Medical, Inc., 2021) after a 65-day review. Its family tree reaches back 15 generations to 1990. 1 of the 44 devices in its family, counting itself, has a Class I recall. 19 later devices descend from it.
- Decided
- May 12, 2021
- Review
- 65 days
- Class
- Class II
- Product code
- QEW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 15 generations to K901627 (1990). 24 ancestors in all, the oldest K780551 (1978). 19 later devices descend from it, 2 citing it directly. 1 of the 44 devices in this family, counting this one, has a Class I recall.
- Root · 15 generations backK901627 Arterial Embolectomy CatheterApplied Vascular Devices, Inc. · 1990 · Recalled
- 11 generations between
- 3 generations backK151313 ZelanteDVT Thrombectomy SetBoston Scientific Corporation · 2015
- 2 generations backK193462 ClotTriever Thrombectomy SystemInari Medical · 2020
- 1 generation backK210190 ClotTriever Thrombectomy SystemIrani Medical, Inc. · 2021
- This deviceK210689 ClotTriever Thrombectomy SystemInari Medical, Inc. · 2021
- Descendant · cites it directly · 15 of its ownK212632 ClotTriever Thrombectomy SystemInari Medical, Inc. · 2021
- Descendant · 2 generations on · 3 of its ownK223000 Artix BGInari Medical · 2023
- Descendant · 3 generations on · 2 of its ownK230912 Artix BGInari Medical · 2023
- Descendant · 2 generations on · 2 of its ownK223609 RevCore™ Thrombectomy Catheter.Inari Medical, Inc. · 2023
- Descendant · 2 generations on · 2 of its ownK223891 Cobra Catheter SystemEndovascular Engineering · 2023
Show all 15 generations
- Root · 15 generations backK901627 Arterial Embolectomy CatheterApplied Vascular Devices, Inc. · 1990 · Recalled
- 14 generations backK960970 Possis Angiojet Rapid Thrombectomy Catheter System, F105…Possis Medical, Inc. · 1996
- 13 generations backK972610 Possis Angiojet Rapid Thombectomy Catheters--F105 Catheter Model…Possis Medical, Inc. · 2000
- 12 generations backK040013 Angiojet Xpeedior 120 Catheter and Angiojet Power Pulse Spray…Possis Medical, Inc. · 2004
- 11 generations backK052256 Angiojet Xpeedior 120 CatheterPossis Medical, Inc. · 2005
- 10 generations backK061951 Angiojet Xpeedior Rheolytic Thrombectomy Catheter, Model Xpeedior 120Possis Medical, Inc. · 2006
- 9 generations backK071342 Angiojet Ultra Xpeedior Thrombectomy Set, Model 105040, 105042…Possis Medical, Inc. · 2007
- 8 generations backK072269 Angiojet Ultra DVX Thrombectomy Set, Model: 106552Possis Medical, Inc. · 2007
- 7 generations backK090253 Angiojet Ultra DVX Thrombectomy Set, Model 106552-001, Angiojet…Possis Medical, Inc. · 2009
- 6 generations backK091593 Angio Jet Ultra DVX and Xpeedior Thrombectomy SetsPossis Medical, Inc. · 2009
- 5 generations backK101406 Angiojet Solent Proxi Thrombectomy Set Model 109676-001Medrad Interventional/Possis · 2010
- 4 generations backK111182 Angiojet Solent Omni Thrombectomy SetMedrad, Inc. · 2011 · Recalled
- 3 generations backK151313 ZelanteDVT Thrombectomy SetBoston Scientific Corporation · 2015
- 2 generations backK193462 ClotTriever Thrombectomy SystemInari Medical · 2020
- 1 generation backK210190 ClotTriever Thrombectomy SystemIrani Medical, Inc. · 2021
- This deviceK210689 ClotTriever Thrombectomy SystemInari Medical, Inc. · 2021
Showing 5 of 19 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K223210 ClotTriever XL Catheter2 generations on · 2023
Most influential descendants
Showing 5 of 19 · See all- K212632ClotTriever Thrombectomy SystemInari Medical, Inc. · 2021 · cites it directly15descendants
- K223000Artix BGInari Medical · 2023 · 2 generations on3descendants
- K230912Artix BGInari Medical · 2023 · 3 generations on2descendants
- K223609RevCore™ Thrombectomy Catheter.Inari Medical, Inc. · 2023 · 2 generations on2descendants
- K223891Cobra Catheter SystemEndovascular Engineering · 2023 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K901627 | Arterial Embolectomy Catheter | Applied Vascular Devices, Inc. | 1990 | 1 |
| −14 | K960970 | Possis Angiojet Rapid Thrombectomy Catheter System, F105 Catheter,Model… | Possis Medical, Inc. | 1996 | — |
| −13 | K972610 | Possis Angiojet Rapid Thombectomy Catheters--F105 Catheter Model 3030C, LF140… | Possis Medical, Inc. | 2000 | — |
| −12 | K040013 | Angiojet Xpeedior 120 Catheter and Angiojet Power Pulse Spray Ancillary Kit | Possis Medical, Inc. | 2004 | — |
| −11 | K052256 | Angiojet Xpeedior 120 Catheter | Possis Medical, Inc. | 2005 | — |
| −10 | K061951 | Angiojet Xpeedior Rheolytic Thrombectomy Catheter, Model Xpeedior 120 | Possis Medical, Inc. | 2006 | — |
| −9 | K071342 | Angiojet Ultra Xpeedior Thrombectomy Set, Model 105040, 105042, 106552… | Possis Medical, Inc. | 2007 | — |
| −8 | K072269 | Angiojet Ultra DVX Thrombectomy Set, Model: 106552 | Possis Medical, Inc. | 2007 | — |
| −7 | K090253 | Angiojet Ultra DVX Thrombectomy Set, Model 106552-001, Angiojet Ultra Xpeedior… | Possis Medical, Inc. | 2009 | — |
| −6 | K091593 | Angio Jet Ultra DVX and Xpeedior Thrombectomy Sets | Possis Medical, Inc. | 2009 | — |
| −5 | K101406 | Angiojet Solent Proxi Thrombectomy Set Model 109676-001 | Medrad Interventional/Possis | 2010 | — |
| −4 | K111182 | Angiojet Solent Omni Thrombectomy Set | Medrad, Inc. | 2011 | 1 |
| −3 | K151313 | ZelanteDVT Thrombectomy Set | Boston Scientific Corporation | 2015 | — |
| −2 | K193462 | ClotTriever Thrombectomy System | Inari Medical | 2020 | — |
| −1 | K210190 | ClotTriever Thrombectomy System | Irani Medical, Inc. | 2021 | — |
| 0 (this device) | K210689 | ClotTriever Thrombectomy System | Inari Medical, Inc. | 2021 | — |
| +1 | K212632 | ClotTriever Thrombectomy System | Inari Medical, Inc. | 2021 | — |
| +2 | K223000 | Artix BG | Inari Medical | 2023 | — |
| +3 | K230912 | Artix BG | Inari Medical | 2023 | — |
| +2 | K223609 | RevCore™ Thrombectomy Catheter. | Inari Medical, Inc. | 2023 | — |
| +2 | K223891 | Cobra Catheter System | Endovascular Engineering | 2023 | — |
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 |
|---|---|---|
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 8 | 1 |
| 2024 | 3 | 0 |
| 2025 | 3 | 0 |
| 2026 | 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.
1 device in this family has 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? (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 |
|---|---|---|---|
| * | K210190 | ClotTriever Thrombectomy SystemSummary page 4…olectomy catheter Classification number 21 CFR 870.5150 Product code QEW Regulatory class II Predicate device ClotTriever Thrombectomy System (K210190) Reference Device Cook Incorporated Dilator Sets (K183036) Description The ClotTriever Thrombectomy System is… | 2021 |
| † | K183036 | Dilator Sets | 2018 |
What descends from it? (19)
See all 192 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 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.
- K223210ClotTriever XL CatheterInari Medical, Inc. · 2023 · 2 generations on · ◆ in the 2023 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 31 years and passes through 8 companies; a new generation was cleared every 1.0 years on median.
- 6 of the 24 ancestors have a recall of any class.
- Of its descendants, K212632 (Inari Medical, Inc., 2021) has gone furthest, with 15 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. 2021, 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 ClotTriever Thrombectomy System is indicated for:
* The non-surgical removal of thrombi and emboli from blood vessels.
* Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel.
The ClotTriever Thrombectomy System is intended for use in the peripheral vasculature including deep vein thrombosis (DVT).
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K210689 · printed Nov 6, 2026
Cite this page
510(k) Report. “K210689: ClotTriever Thrombectomy System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K210689
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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